Superiority Claims

Week in Review, September 17, 2014

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A new study reveals surprising information about FDA panelists and their ties to manufacturers seeking regulatory approval, the DOJ files a False Claims suit against a neurosurgeon and a spinal implant company, the FTC accuses two companies of trying to stymie generic competition for Androgel, and a collection of advocacy groups ask CMS for an indirect payments exemption.

Ahoy there mateys! Stand fast, secure the rigging, and let us hear your best “arrr.” Yes, “Talk Like a Pirate Day” is on the horizon. As you prepare to weigh anchor and hoist the mizzen, we strongly recommend you avoid the parrot on the shoulder idea – that didn’t end well for one of the old salts here at the Week in Review offices last year. The big day isn’t until Friday, so we’ll fill the time with this week’s Compliance News in Review.

It’s not the amount of treasure involved, but rather the type of treasure, that may be more influential in the decisions made by FDA panel members when they decide which drugs to recommend for regulatory approval. A recent study found that panelists who have financial ties only to the drug manufacturer seeking approval are 1.5 times more likely to vote favorably for the company than members with no ties. However panelists who have ties to the company seeking approval and its competitors are no more likely to recommend for approval than those panelists who have no ties. Panelists with multiple relationship may not have a sense of loyalty to any one particular manufacturer. In addition, panelists who serve on advisory boards are more likely to approve a drug than panelists who have research or consulting relationships with the manufacturer.

A physician and spinal implant company have found themselves on the wrong end of a hornswaggle claim by the Department of Justice. The agency has filed a False Claims Act suit against a Michigan neurosurgeon, as well as spinal implant company, Reliance Medical Systems, and two of its distributorships. The company is accused of paying kickbacks through physician-owned distributorships (PODs). The government alleges that the company set up the PODs to induce physicians to use its spinal implants. The physician involved received payments through a POD in which he had an ownership stake. He is also accused of performing unnecessary procedures on patients who did not need spinal implants.

The Federal Trade Commission (FTC) is suing Abbvie and Besins Healthcare for running a rig and trying to prevent generic competition for the product Androgel. The agency claims the companies filed baseless patent infringement lawsuits in an effort to prevent potential generic competitors from entering the market. While the lawsuits were pending, Abbvie then entered into a pay-for-delay deal with Teva in order to postpone the launch of its generic version of the product. The FTC is asking the court to declare that Abbvie and Besins Healthcare violated the Federal Trade Act, and is seeking disgorgement of profits.

The mutiny against indirect payment disclosures under Sunshine continues to grow. A collection of 64 patient advocacy groups sent a letter to CMS requesting an exemption for indirect payments to the groups. The letter claims drug and device manufacturers have no discretion on how funds provided to patient advocacy groups are directed. It also suggests that the process of determining how a manufacturer’s funds are allocated places an unnecessary administrative burden on the groups.

As we heave to on this week’s journey into the world of compliance, we end with a question: arrr your sales representatives prepared with the up-to-date content on topics like the Sunshine Act, HIPAA, and Good Promotional Practices? The PharmaCertify™ suite of solutions offers your team compliance-focused information where and when they need it most – in the field and at their fingertips.

Have a great rest of the week everyone.

Week in Review, July 9, 2014

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CMS makes changes to reporting deadlines and requirements, Canada continues to collect date about the effects of off-label use of drugs, and Medicines Australia updates its Code of Conduct.

You scream, I scream, we all scream for ice cream! And we’ll be doing a lot of screaming because July is National Ice Cream Month. (July – 31 days. Baskin-Robbins – 31 flavors. Coincidence?) Whether on a cone, in a cup or topped with sauces, fruit or confections, July is a great month to enjoy this cold treat. And gone are the days when Tutti Frutti was the outrageous flavor. Now, along with the likes of Cookies & Cream and Rum Raisin, you can have your pick of Chocolate-Chili, Roasted Garlic, or Mushy Green Peas. As you ponder your favorite flavor (bizarre or otherwise) for beating the July heat, we offer our own scoop with this week’s News in Review.

The deadline for submitting Phase 2 data melted away, sort of, last week. CMS sent out an email essentially extending the deadline for submitting Open Payments Phase 2 documents to July 7. In the e-mail, CMS said it wanted to assure accuracy and completeness of the reports and attestations and that penalties would not be enforced for non-compliance until after July 7.

Also melting away could be the CME exclusion in final rule for the Sunshine Act. CMS is planning to propose a change to the exemption for reporting CME payments. The current rule allows an exemption for three reasons: the program is accredited by certain organizations, the physician isn’t paid directly by the manufacturer, or the manufacturer doesn’t influence the selection of speakers. CMS ultimately decided to remove the exclusion due to the redundancies involving indirect payments that occur when the manufacturer is unaware of the recipient. The agency also does not want to appear that it is indicating support of certain accrediting bodies by continuing to specifically name them in the exemption. The proposed changes will appear in the July 11 Federal Register.

And if the CME change isn’t enough, CMS has a few other toppings to add to the final rule sundae. The agency is also proposing that “stock, stock options, and other ownership interests” not be one category, but three. Other changes include the requirement that all manufacturers, including device manufacturers, use the product’s marketed name on reports and the removal of the “definition of a covered device” from the rule.

Canada’s Health Minister, Rona Ambrose, is serving up a scoop or two of new information about serious side effects resulting from off-label drug use. Health Canada has been collecting the information for several years, but technical issues prevented it from making the database of information publicly available. The group is planning a systems upgrade that will allow the regulator to share the database. No timeline for when the public can expect to access the information has been released.

Medicines Australia is looking for approval of its latest flavor. The organization has submitted the 18th edition of its Code of Conduct to the Australian Competition and Consumer Commission for authorization. The new Code includes requirements for the reporting of transfers of value from industry to healthcare professionals. If authorized, the Code will become effective January 2015, with the new transparency requirements going into effect October of 2015. However, not everyone is happy with the result. A provision requiring manufacturers to obtain permission from physicians to allow their name to be published with the payment data, has members of the Greens political party very concerned. A spokesman said the party was considering reintroducing legislation to make the reporting of transfers of value to physicians a legal requirement.

Sunshine and transparency will no doubt continue to be a popular flavor, both here and abroad, for the distant future. That’s why we are adding a global transparency focused module to our growing list of PharmaCertify™ off-the-shelf learning solutions. To learn more about the module or see a content outline, contact Sean Murphy at smurphy@nxlevelsolutions.com.

Have a great rest of the week!

Week in Review, May 5, 2014

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UCLA settles with a surgeon over conflicts of interest, CMS announces a timeframe for Phase 2 of Open Payments data submission, qui tam lawyers pour through the recently released Medicare payment data and PhRMA weighs in on simplifying product warning information.

Not so long ago in a galaxy…well, right here…the greatest achievement in cinema was celebrated (yes, we’ll admit it, we’re often given to hyperbole). With all due respect to Bogie and Bacall and Orson Welles, we’re of course referring to this past weekend when the Fourth of May was with us, and we celebrated Star Wars Day. Then, on Monday we had to deal with the Revenge of the Fifth. Rather fitting don’t you think? If Star Wars isn’t your particular cup of blue milk, feel free to jump right to the earthly compliance news of the week with this issue of the News in Review.

10,000 credits in advance may get you a ride on the Millennium Falcon, but it took 10 million dollars to settle a retaliation suit between a UCLA surgeon and the University of California Board of Regents. The surgeon, who was head of the orthopedic surgery department, raised concerns about physicians’ financial relationships with medical device companies. He claims his complaints were ignored and he was then denied patient referrals and prevented from participating in grants. In settling, UCLA claims it chose “to end a prolonged conflict and permit UCLA Health Sciences to refocus on its primary missions of teaching, research, patient care and community engagement.”

Open Payments: Episode 2, coming soon to an industry company near you. CMS has announced that applicable manufacturers can expect Phase 2 of Open Payments data submission to be open late May or early June. During Phase 2, applicable manufacturers and GPOs should:

  • Register any authorized officials not registered during Phase 1
  • Complete the registration for entity and the authorized official (supplemental information is required)
  • Verify entity profile information is correct
  • Upload, verify and attest to accuracy of payment data

Additional roles within the Open Payments system may also be assigned during Phase 2. CMS is preparing tutorial videos to assist applicable manufacturers and GPOs with implementation.

Qui tam lawyers have been mining the recently released Medicare payment data almost as aggressively as the Empire mined the Tibanna gas mines at Bespin (wow, we went full out geek there). The organization known as Taxpayers Against Fraud has lawyers pouring through the data looking for physicians who prescribe high numbers of a particular product. Obtaining this type of data previously required a subpoena. Is this a foreshadowing of what to expect once Sunshine data is released? Sunshine data might be used to demonstrate alleged instances of kickbacks, or infer that a company is involved in off-label marketing when a physician’s specialty doesn’t align with the approved use of a product.

They may not be well-liked by the hard core fans, but the Ewoks certainly proved the power of “keeping it simple.” Seriously, a bunch of teddy bears held off the Empire with rocks and logs! PhRMA appears to share this simplicity sentiment when it comes to the warnings in DTC ads. When the FDA asked for comments regarding a study focused on whether simplified warning information would help patients better understand the risks, PhRMA didn’t hesitate to voice its opinion. The organization believes shorter or less-complex warnings would help patients understanding the risks and motivate patients and healthcare providers to seek additional information about the drug.

With Phase 2 of Open Payments registration and data submission about to begin and the data publication expected not too far in the distant future, the Sunshine Act is burning brighter than the two suns of Tatooine. Make sure your team understands the nuances of the law The Sunshine Act: The Federal Physician Spend and Disclosure Law from the PharmaCertify™ suite of off-the-shelf eLearning modules.

Well folks that brings us to the end of this episode. Have a great week, and may the Force be with you!

Week in Review, August 12, 2013

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The PharmaCertify Team

Break out those LPs and dust off your turntable, Monday was Vinyl Record Day! Count us among those who still miss that crackling and popping quietly emanating from our favorite disco, rock or R&B album. And we can’t forget all of that amazing cover art – Kansas, Left Overture, Yes, Relayer, or of course the Beatles, Sargeant Pepper’s Lonely Hearts Club Band, just to name a few. Before we lose ourselves (and you) too deeply in the musical formats and artwork of yesteryear, we first turn our attention to the rhythm and blues of this week’s News in Review.

Allegations of bribery by pharmaceutical companies in China continue to spin. Documents provided to a Chinese media outlet accuse Sanofi of paying $280,000 in bribes to over 500 doctors. In the documents, a whistleblower claims doctors were paid 80 yaun every time a patient bought one of the company’s drugs. Sanofi officials claim they are taking the allegations very seriously, but made no comment as to whether they were conducting their own investigation.

The DOJ is marching firmly to the False Claims drum beat, as the agency has filed a brief asking a federal appeals court to overturn a decision by a US district court against Takeda. The whistleblower suit claimed the company hid adverse events associated with a pair of drugs, causing those drugs to be prescribed more often than if the adverse events had been known, and subsequently causing false claims to be submitted. A U.S. district court judge dismissed the case, saying the whistleblower had failed to provide evidence of the false claims, and the adverse events were not material to the decision by the federal government to pay for the drugs.  The ruling went on to assert that False Claims Act liability could not be premised on failure to report adverse events to the FDA. The DOJ believes that adopting such reasoning could affect the government’s ability to enforce the False Claims Act.

The CME Coalition has a new release to help CME program providers and others navigate the Sunshine Act. The group’s Sunshine Act Compliance Guide provides recommendations on issues like meals for attendees and speakers and unaccredited CME. The guide also features a “compliance decision tree” to help CME program organizers make quick decisions on physician payments.

CMS had a hit of its own with the release of more FAQs on the Open Payments site. The list now includes information on how newsletters that include disease state information should be handled; an answer on whether textbooks donated for general use are reportable; and clarification on the 90 day exclusion for the loan of a medical device.

It’s been more of the same old sad song for reps trying to access oncology practices over the last year. For the second year in a row, oncologists were the most restrictive specialty, with 65% enforcing moderate to severe access restrictions. New products seemed to be the key, as reps carrying a new product saw doctors 10 times per year on average, compared to 7 times per year for those detailing older drugs.

Well, that’s about it for this week’s Review. If you’re looking to round out your compliance training playlist, PharmaCertify’s Good Promotional Practices module covers the “classics,” like gifts, meals and entertainment, while mixing in new topics like promotion through social media.

Have a great week everyone and we’ll see you right back here on this same frequency next week!

Week in Review, July 29, 2013

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The PharmaCertify™ Team

Christmas in July. It’s gone from a fun little saying to a marketing gimmick to help clear out the last of the summer merchandise with Christmas shopping-esque sales. Oh, and let’s not forget the cable networks breaking out all your favorite holiday movies and specials in an effort to gain summer viewers. (BTW…still waiting on someone to show the Star Wars Christmas special. Where’s the love??!!) So, who are we at the News Week in Review to buck this trend? Pull out your jingle bells and put on your Santa hat, it’s time for Christmas in July in this week’s News Week in Review.

Facilitation payments – naughty or nice? Well in certain countries they are definitely naughty, and while “nice” may not be the exact term one wants to use when talking about them, facilitation payments are certainly a reality of doing business in some countries. A columnist with Compliance Week points out that no compliance officer wants to see bribes labeled as facilitation payments, but if paid as intended – to speed up an action a government official would do anyway – then there shouldn’t be an issue. Governments are increasingly including bans on facilitation payments in their anti-corruption laws, but are such bans realistic considering the reality of the global business environment? The U.K. Bribery Act was the first to ban facilitation payments, but now there is a movement within the government to repeal that section of the law. Canada’s recent amendment to its anti-corruption law will phase out facilitation payments, but the no time table was indicated for the phase out.

The Chinese government has been busy handing out lumps of coal as it expands its probe into the pharma industry. Thirty-nine hospital workers will be punished for taking bribes, two more Chinese employees with Astra-Zeneca were questioned in connection with an investigation of that company, and an American from an unnamed company was detained by the government in connection with an industry investigation. A spokesperson for the U.S. Embassy said they were aware of the situation and were providing appropriate assistance.

The industry can expect some unwrapping of the details relative to drug patent settlements from the Federal Trade Commission going forward. Speaking to lawmakers, FTC Commissioner Edith Ramirez said the agency plans to continue on with current pay-for-delay cases it is litigating and will be investigating new settlements to determine if they are legal. She acknowledged that most patent settlements do not involve a pay-for-delay component but the FTC’s goal will continue to be to stop the anti-competitive settlements that do.

In Chile, where it actually feels like Christmas, the Chilean Medical Association (CMC) and the Council of Pharmaceutical Innovation (CIF) signed an agreement to address conflicts of interests between the industry and healthcare professionals. The agreement prohibits the provision of donations and gifts to influence healthcare professionals’ decisions and paying physicians to conduct clinical trials of new drugs. The Presidents of both organizations said they hoped the agreement would show the public they are serious about stopping conflicts of interest. The signing of the agreement comes in advance of a vote by the Chilean legislature on the Pharmacy Law which will bring transparency to the relationship between physicians and the industry.

The need for Rudolph’s shiny nose is starting to dwindle as the CMS starts clearing up some of the fog surrounding Sunshine requirements. Andrew Rosenberg of the CME Coalition met with CMS’ Sunshine implementation team to clarify some of the requirements related to reporting payments at CME events. He was able to confirm that events considered accredited under the final rule the following are exempt from reporting; speaker travel and lodging, attendee buffet style meals and most educational items. Rosenberg was pleased with the clarification, and said, “The goal here should be to continue to encourage doctors to pursue CME and not create a barrier for uncertainty about the rules.” The CME Coalition hopes to see CMS make changes regarding the accrediting bodies whose programs fall under the CME exemption in the final rule. Rosenberg points out there are number of other accrediting bodies that have adopted ACCME standards and follow the same rules as the organizations listed in the final rule. He also said that CME events supported by accrediting bodies with rules similar to CMS’ final Sunshine rules should be exempt from reporting. The Coalition plans to continue to push this point with CMS and Rosenberg believes eventually they will win on this issue.

Christmas may still be several months off, but the start of Sunshine Act data collection is just a few days away! It is essential that those who interact with physicians understand the requirements under Sunshine to avoid a “garbage in- garbage out” scenario with all necessary data. To ensure a clear understanding of Sunshine consider our customizable, off-the-shelf module. Click here to learn more about our effective eLearning program.

Unfortunately, we must wrap up our little holiday fantasy and return to the warm reality of summer. Have a great week everyone!

Week in Review, July 22, 2013

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The PharmaCertify™ Team

Apparently, the British media nicknamed Kate Middleton “Waity Katie” while she waited on Prince William to pop the question, and she proved to live up to that nickname again while she and her prince waited on the arrival of their first born. The waiting is finally over! As of press time, the Duchess of Cambridge was in labor. While the world waits to learn if the third in line for the throne is a boy or a girl, we’ll help you pass the time with this week’s News Week in Review.

With Sunshine’s due date quickly approaching, CMS released more FAQs and a couple of apps to help track payments. The latest additions cover the definition of an accredited CME program, and how (sort of) payments to physicians for promotional speaking engagements should be categorized. As to the latter question, CMS states those payments could be categorized as “honoraria” or “payments for services other than consulting,” depending on the ”specific facts.” Hmm…that’s helpful. The apps are available for industry professionals or physicians and are primarily designed to help with the payment tracking process.

The Journal of the American Medical Association has a gift for those submitting studies for publication. JAMA will no longer require independent statistical analysis for clinical studies funded by the industry. JAMA’s editor-in-chief cited improvements clinical trial reporting, including clinical trial registries and more transparency in trial data, as the reason for dropping the requirement.

There’s a new arrival in the Pennsylvania legislature. A bill has been introduced to institute a state false claims act. The bill has many of the same provisions as the federal False Claims Act, including protection and incentives for whistleblowers.

On the bribery front, China has been the focus of a number of bribery investigations in all business sectors, with the pharmaceutical industry taking center stage. The focus has been on GSK to this point, but several other pharmaceutical companies are under investigation by Chinese law enforcement, prompting one multinational company to tell employees in China to choose compliance with Chinese regulations over winning business. The regulatory climate, poorly paid doctors, and underfunded hospitals have fueled the fire for bribery in China, and made the industry a target for enforcement agencies. Chinese officials may also have another reason for focusing on the industry – the rising cost of healthcare in the country. Those costs are expected to top one trillion dollars by 2020.

Canada has decided to dress up its anti-bribery law with new amendments designed to strengthen the law. The amendments make it easier to investigate and prosecute offenses, and exposes corporate directors, officers and employees to expanded criminal liability. A criminal books and records offense (a civil offense under the FCPA) was added, as was a provision for phasing out facilitation payments. The maximum penalty for individuals was increased from 5 to 14 years imprisonment.

US law enforcement delivered multiples last week; multiple settlement announcements that is.  Amgen agreed to pay $15 million to settle allegations it violated the federal Anti-kickback Statute and False Claims Act. According to prosecutors, the company used data purchase agreements to incentivize oncologists to use one of its chemotherapy drugs. Mallinckdrot Inc. also agreed to pay $3.5 million to settle allegations of violating the Anti-kickback Statute and False Claims Act.  The company was accused of incentivizing doctors to prescribe “outdated and third-rate drugs.” The whistleblower suit claimed the company paid speaking and consulting fees to physicians in exchange for prescribing its anti-depressants and sleeping pills. The suit claimed that without the incentives, the drugs would not have been prescribed, since several of the drugs were approved decades ago.

Well, that’s about it on the news front for this week. As people around the world monitor their mobile devices for news of the royal delivery, we’ll use this opportunity to ask if you’ve incorporated mobile solutions into your compliance plan. PharmaCertify’s mobile apps and iPad-compatible training modules bring critical compliance content where your staff where they need it most – in the field and at their fingertips. For more information or a demo, contact Sean Murphy at 609-466-2828, ext 25 or smurphy@nxlevelsolutions.com.

Have a great week everyone!

Week in Review, July 8, 2013

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Te PharmaCertify™ Team

Well, here we are again…Monday already. Back to work we go, after what was hopefully a long weekend for you. While having one or two days off is refreshing, it tends to leave you a little foggy on Monday, doesn’t it? Never fear, we kept our ear to the ground throughout the July 4th holiday and what better way to jump start the week than with the News in Review.

A study finds that Canadian medical schools’ policies about interactions with industry are falling short. The study evaluated the conflict of interest policies of Canada’s seventeen medical schools in twelve categories, including samples, curriculum and scholarships. In most of the categories, only one school had what researchers considered restrictive policies. Some of the schools have developed new polices or revised existing policies since the study was conducted in 2011.

Bribery is no small matter, and a new report finds that bribery and corruption risks are on the rise. Nearly half of the businesses in the study say their bribery and corruption risks have increased in the last two years, and they expect that trend to continue in the future. Expansion into new markets and heightened enforcement are the top two reasons cited for the increase in risk. Nearly 20% of the businesses in the study said they either don’t require employees to read their anti-bribery policy or they don’t even have one in place.

Several GSK employees were detained by Chinese officials for suspected “economic crimes.” The detention follows allegations from an internal tipster. The company said it was aware of an investigation by Chinese officials, but the nature of the investigation was not known.

The London Police will soon start training businesses about the UK Bribery Act. The training, which is slated to begin in September, will be conducted in conjunction with the British Standards Institution, a business standards company. The London Police have 25 bribery cases under investigation.

Transparency is going global, as the European Federation of Pharmaceutical Industries and Associations (EFPIA) is now requiring its member companies to disclose payments and transfers of value to physicians. The requirement was adopted by the EFPIA’s board last month, and will require member companies to begin publishing the information in 2016.

Medical device manufacturer, Baxano Surgical, formerly TransS1 Inc., agreed to pay $6 million to settle allegations it violated the False Claims Act. The company was accused of causing healthcare providers to submit incorrect diagnosis or procedure codes to Medicare for the use of its spinal fusion products. The government claims the company advised providers to use a code intended for more invasive spinal procedures than those associated with use of the their own product. The company was also accused of providing kickbacks to physicians in the form of consulting and speakers fees as an inducement to use its product, and for promoting the product for unapproved uses.

The settlements for violations of global bribery law are growing in numbers and dollars. That’s why PharmaCertify’s, Understanding and Preventing Bribery in the Global Life Sciences Marketplace is designed to help your staff and representatives evaluate the degree of risk inherent with every transaction and understand the level of due diligence and monitoring needed to ensure compliance with the FCPA and the UK Bribery Act. Contact Sean Murphy at smurphy@nxlevelsolutions.com to learn more about the module.

Have a great week everyone!

Week in Review, July 1, 2013

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The PharmaCertify™ Team

Strike up the band, fire up the barbecue and prepare to proudly fly the flag high! It’s almost Independence Day; the time of year when, despite our differences, Americans come together to celebrate the birth of our nation. But before we find the best spot on the curb to watch the parade pass by, there is still the matter of the work week, albeit a short one. What better way to get us started, than with the News Week in Review.

The US Supreme Court has certainly been busy. In a 5-4 decision, the Court decided that a federal law regarding pharmaceutical promotion pre-empts a person’s ability to file a state suit over a poorly designed generic drug. The case involved a woman who sued Mutual Pharmaceuticals after she suffered an adverse event allegedly caused by one of the company’s generic products.

The British are coming! The British are coming! And they’re serious about anti-bribery. Speaking at an anti-corruption conference, the Serious Fraud Office’s chief investigating officer, Kevin Davis, revealed the organization is actively investigating two cases under the UK Bribery Act. Despite drastic reductions in the SFO’s budget, Davis said cost would not deter the SFO from pursuing bribery cases, and stressed the importance of companies having robust procedures in place to deal with bribery. Davis also discussed the shift in the SFO’s approach to handling bribery cases. He told conference attendees, “We are not an agony aunt or advice service. The SFO had tipped too far towards settlements.”

Medicines Australia took another step toward joining the transparency parade. The agency’s Transparency Working Group released its model for reporting physician payments. The model is similar to the US Sunshine Act, and is currently being reviewed by the larger organization.

John Hancock would be a bit disappointed with recent petition response from the FDA. The agency was petitioned by a non-profit group to increase the type size on DTC ads. The group is concerned that the type is too small for the elderly to read and they are hopeful that a change will reduce accidental overdose and adverse events. The FDA rejected the petition, saying while the concerns are valid, current regulations and two draft guidance policies address the issue satisfactorily. The group was disappointed with the decision, saying that the FDA had turned “its back on millions of patients and consumers nationwide.”

Medtronic declared its independence from an FCPA investigation. In a regulatory filing, the company said it was informed by the SEC and DOJ that the agencies would not be prosecuting the company on FCPA charges. In 2007, the company received letters from both agencies, seeking information on potential violations of the bribery law.

Well, that’s it for this week’s Review. Amidst your plans for the weekend celebration, it’s easy to forget that we are now under the 30 day mark for Sunshine Act data collection to begin. PharmaCertify’s The Sunshine Act: The Federal Physician Spend Disclosure Law covers the reporting requirements and includes practical tips for tracking and reporting crucial spend data.

Have a great week and July 4th celebration!

Week in Review, June 24, 2013

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The PharmaCertify™ Team

According to the meteorologists and the astronomers, summer has begun! Time to hang ten and catch a wave! We know…on a Monday, the weekend beach time seems a little far off, but at least we can dream, as we enjoy an iced coffee or other beverage of choice. Before you drift off to the shores of daydream land though, check out what the tide brought in…this week’s News Week in Review.

According to one congressional report, it’s not just sand dollars the FDA is holding onto recently. The US House Committee on Appropriations criticized the agency for carrying one billion dollars of unobligated user fees halfway through the fiscal year. Congress expected some carryover in user fees, but the one billion dollar figure was quite the surprise. Going forward, the FDA Commissioner will submit a report about the fees to the Appropriations Committees and what programs those fees will support.

A new report finds that objections from regulatory departments are not the reason pharma companies are slow to catch the social medial wave. When asked about the social media mindset at the end of 2012, twelve pharmaceutical executives said the biggest obstacles were teamwork issues. The executives pointed to a lack of internal expertise in social media and an unwillingness to participate by various groups within the organization. An inability to measure the return on investment was also cited.

Efforts at passing legislation similar to the Sunshine Act have wiped out in Australia. The Australian Senate Finance and Public Administration Legislation Committee rejected a bill that would have required disclosure of physician payments by pharmaceutical manufacturers. Instead, the committee agreed with industry and medical professional stakeholders in stating that self-regulation was a better way to handle the disclosures. Some believe that the bill failed because Medicines Australia is currently working on payment transparency requirements, which has limited the scope of the bill.

In the world of generics, the U.S. Supreme Court has ruled that companies can be sued over pay for delay deals that slow the entry of generic drugs into the market. According to the Federal Trade Commission (FTC), the delays cost consumers $3.5 billion a year. The decision opens drug companies to a wave of suits by wholesalers, insurers and antitrust enforcement agencies.

CMS want physicians to know the agency is dedicated to making sure they don’t get burned by Sunshine. A spokesperson from CMS told a gathering of the American Medical Association’s House of Delegates that data accuracy is the agency’s top priority.  The spokesperson said doctors can challenge the information if they feel it is inaccurate, and she encouraged them to take an active role in the process. CMS is developing tools, like a smart phone app that syncs with manufacturer reporting activity, for physicians to monitor the process and dispute results. The outgoing AMA president said the Association has started a Sunshine resource page to educate physicians about the requirements of the laws and will be holding webinars and hosting online modules for additional assistance.

It’s not all sunny skies concerning data accuracy at CMS. According to a report from the OIG, the database housing the physician information required for the Sunshine reports is largely inaccurate. Apparently, the National Plan and Provider Enumeration System (NPPES), which houses National Provider Identifiers (NPIs), contains inaccurate information in at least one field, 48% of the time. The OIG made several recommendations to correct the problem, including the implementation of program integrity safeguards in the Program Integrity Manual.

Well. that’s it for “start of summer 2013” edition of the News in Review. If the Sunshine Act is hot on your list of training topics for 2013, PharmaCertify has added The Sunshine Act: The Federal Spend Disclosure Law to its curriculum of customizable off-the-shelf compliance training modules. Contact Sean Murphy smurphy@nxlevelsolutions.com to learn more or receive a content outline.

Have a great week everyone!

Week in Review, June 17, 2013

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The PharmaCertify™ Team

Fore! Even for the casual golf fan, the U.S. Open offered moment-to-moment nail biting action over the weekend. The greens at Merion offered twists and turns the golfing world will be discussing for months to come. When a major ends with all of the participants, including the winner, being under par, the course indeed had the last laugh. As the pros are left wondering what happened to their razor sharp instincts and trusty putters, we clear the fairway for another week of busy compliance news.

The lie…rather important in golf, and not a good idea when testifying before the grand jury, as a Virginia doctor discovered. The doctor was indicted for lying to a grand jury during an investigation into a case involving Orthofix and the illegal marketing of a bone growth product. Prosecutors say the doctor lied about falsifying medical records in order to justify Medicare reimbursement for procedures using the company’s bone growth stimulators.

As we witnessed over the weekend, golfers need to take whatever risk is needed when the tournament is in jeopardy on the back nine. For pharma and med device companies, FCPA risk is an inherent part of the clinical trials process. Nearly 75% of clinical trials occur overseas, and the physicians conducting the trials are often considered foreign officials under the FCPA. Due diligence of those CROs bring used to manage trials is critical to keep the risk of bribery low.

Are governments “laying up” in their anti-corruption efforts? According to the World Bank Institute, worldwide bribery amounts to one trillion dollars every year. Enforcement tends to focus on the corporation paying the bribe, which is the easier, safer and more immediate solution to deal with the problem. What about the person accepting, or soliciting the bribe? More often than not, companies are not offering bribes outright, but are having the bribes coerced from them in order to conduct business in a specific area. The International Anti-Corruption Resource Center (IARC), a non-profit organization, is providing training to local law enforcement and investigatory agencies to help spot issues like bid rigging.

It was a good day for Britain on Sunday when Justin Rose claimed the U.S. Open title. The news hasn’t been quite so good for British drug maker GSK though. The company is investigating allegations that doctors in China were paid to prescribe its drugs. An anonymous source informed the GSK board that doctors were offered cash, speaking fees, expensive dinners and travel in exchange for writing prescriptions. GSK says it has spent four months investigating the allegations and company officials have yet to find any evidence of bribery.

India may not be on the leader board when it comes to transparency in physician-industry relationships. While the U.S. and France have transparency laws in place, and countries such as Belgium and Slovakia, are in the process of passing transparency laws, India’s government has ignored recommendations from doctors and a parliamentary health committee to implement a law.

Medicines Australia’s Transparency Working Group is dealing with a deep divide as it develops a transparency program. There are two programs under consideration; one is similar to the Sunshine Act, with payments over $10 having to be reported and a $100 threshold for smaller payments; the other would require payments over $25 to be reported and no threshold for smaller payments. Supporters of the more stringent requirements say even the lower value payments can create a sense of reciprocity or obligation for the physician. Those supporting the less stringent requirements say the $10 threshold will require companies to implement new systems to capture the data, while current systems could handle the $25 threshold.

The New England Journal of Medicine recently teed up a couple of articles about the Sunshine Act. The first was authored by the architects of CMS’ National Physician Transparency Program. It provided information about the requirements of the law and suggested physicians help manufacturers in the reporting process by tracking payments themselves and providing companies with their NPI and state license numbers. In the second article, the authors claim the Act may not regulate the provision of payments to physicians, but it will change behavior by showcasing potential conflicts of interests. Further, the law will provide a “free flow” of information related to healthcare costs, which will be of benefit to the government and to private payers.

As we head to the clubhouse, you may have noticed that transparency is certainly the topic of the week. With Sunshine Act data collection set to begin in just a few weeks, now is time to train sales reps, research personnel and others who interact with physicians. PharmaCertify’s off-the shelf eLearning module, The Sunshine Act: The Federal Physician Spend Disclosure Law, covers topics like reportable expenditures, food and beverage, and the process for data review. As with our entire suite of compliance-focused training, the Sunshine Act module is easily customized to incorporate your policies and procedures.

Have a great week everyone!