Compliance News in Review, June 29, 2015

The universe has spoken – summer is officially here. (If you’re living in a part of the country that is in the midst of a heatwave, I’m sure you’re thinking “never mind what the calendar says, summer has been here for two weeks!”) Now that we’ve crossed the solstice for another year, let’s take a look back at how spring ended, in this issue of the Compliance News in Review.

PetroTiger escaped the heat of an FCPA prosecution. In a highly unusual move, the DOJ announced it would not charge the oil company with violating the FCPA. Three company executives have already pled guilty to the same charges, and typically charges against the company follow. In this case, the DOJ decided otherwise, saying PetroTiger had fully cooperated with the investigation.

The Sunshine Act is never far from the minds of physicians, no matter the season. 100 physician organizations sent a letter to Representatives Richard Michael Burgess and Peter DeFazio expressing support for a bill that would exempt payments for CME and educational materials from the Sunshine Act. The Representatives introduced the bill in an effort to correct the “unintended consequence of over-burdensome reporting requirements that made access to educational materials for physicians difficult to obtain.” The physician groups claim that the dissemination of medical education materials has already slowed as a result of the law.

The sun has set on an off-label marketing case for a former Merck company. The company settled with the government for $5.9 million in an illegal marketing case involving its former Inspire Pharmaceuticals unit. According to prosecutors, Inspire claimed its pink eye drug was effective for treating blepharitis, a condition for which the drug was not approved. According to the government, the promotion of the drug for the off-label use led to false claims being paid by government healthcare programs. Merck claims the activity occurred before it acquired the company. Inspire was sold to Akorn in 2013.

FDA officials shed some light on advertising and promotion enforcement at the 2015 Develop Innovate Advance conference. Deborah Wolf of the Division of Premarketing and Labeling Compliance discussed several promotional issues surrounding devices, including the risk of physicians promoting devices for unapproved uses.

Tom Abrams of the Office of Prescription Drug Promotion said the most common areas of enforcement for his office involved unsubstantiated superiority claims; overstatement of efficacy; and omission and minimization of risk information. Lisa Stockbridge of the CEBR’s Advertising and Labeling branch said that biologics faced many of the same issues as prescription drugs. She referenced an untitled letter sent to a company for claims made by the company’s CEO in a video interview posted on the company website, which included unsubstantiated claims about one of its products.

Obviously, product promotion remains a hot topic, and with good reason. As we continue to see in the news, off-label promotion violates the FDCA and implicates the False Claims Act, and can result in pretty hefty penalties. However, training needs to go beyond on-label promotion, and cover the topics referenced in the stories above. Misleading statements, false efficacy claims, and omission of risk lead to untitled letters from the FDA, and as seen in the 2014 Shire case, can be used by the DOJ in cases against manufacturers.

All facets of promotional speech need to be covered in your compliance training, especially since the FDA has essentially deputized healthcare professionals to be on the lookout for promotional speech missteps through their Bad Ad program. More and more eyes are focused on product promotion, so making sure everyone responsible for making promotional statements, in any form, is aware of the requirements, is more critical than ever.

That’s the news for this edition. Stay cool and have a great week everyone!

Week in Review, May 13, 2015

European Medicines Agency changes its conflicts of interest policy, ACCME updates its requirements related to the disclosure of commercial support, Siemens may be facing corruption charges in China, Bio-Rad tries to block access to FCPA settlement documents, the FDA schedules a summer session with stakeholders to discuss the topic of off-label, and another pharmaceutical company adopts the First Amendment argument in a fight to promote off-label.

Well, the world welcomed a new royal at the beginning of May, and last week, we even learned the name of the latest little princess, Charlotte Elizabeth Diana. A lovely name for a lovely little girl, and a touching tribute to the proud papa’s mother. Of course, if you’re not an Anglophile, you undoubtedly couldn’t care less, so we’ll quickly move on to our own little bundle of joy…the latest version of the Compliance News in Review.

In other news from across the sea, the European Medicines Agency (EMA) has made changes to its conflicts of interest policy. The agency will no longer allow individuals with connections to the pharmaceutical industry, or those who know they will be working for the industry, to sit on drug review panels. The previous policy left that decision up to the individual.

The ACCME has issued a royal proclamation updating its requirements for disclosure of commercial support. CME providers will now be allowed to use tabs, hyperlinks, or other electronic means to communicate commercial support to attendees. The ACCME says the move is an effort to “simplify compliance expectations and make them consistent across activity types.” The organization expects learners, as they always have, to receive disclosure information prior to the start of a CME session.

Siemens announced that its healthcare unit’s marketing and business practices are being investigated by Chinese regulators. The company denies media reports that the investigation deals with corruption, and says that it is working with regulators to resolve the matter. A Chinese government website stated that regulators were not investigating the company over bribery concerns. Siemens sells medical equipment and biochemical tests in China.

Bio-Rad raised the drawbridge on a records request from an investor. That investor has now filed a petition to have access to records related to Bio-Rad’s FCPA settlement. In 2014, the company entered into a non-prosecution agreement with the DOJ and accepted an Order issued by the SEC to resolve the matter. The investor made a request for records that related to the bribery allegations, but the company said there was no proper purpose for the records and the request did meet certain legal requirements.

The FDA will hold audience with the public during the summer to discuss off-label promotion. The agency says the meeting is being called to discuss the issue with a variety of stakeholders. The industry has been vocal about how the regulations infringe on First Amendment rights and have called on the FDA to relax its regulations. Critics worry that allowing companies to promote off-label will lead to less clinical trials and risks to patient safety.

One drug maker has decided to not wait for that summer meeting to take action. Amarin Pharma has filed suit against the FDA over its ability to share off-label information with physicians. Lawyers representing the company say the company is within its First Amendment Rights to share the information, as long as it is truthful and not misleading. The lawyers believe Amarin is the first company to pre-emptively sue the FDA over the issue. At the center of the suit is the company’s ability to share company-sponsored clinical trial information with doctors. The information indicated that the drug may be helpful for a wider patient population than what was approved. Lawyers for the company say the company knows physicians are already prescribing the drug off-label for a wider patient population, and more information, not less, should be shared with the physicians. A director with the health advocacy group, Public Citizen, says if the suit succeeds, it will undermine the FDA’s drug approval process. The FDA had no comment.

With that news of the on-going battle over off-label, we proclaim this issue of the Compliance News in Review as complete. Clearly, the focus on off-label isn’t going away anytime soon. That’s why we continually update our PharmaCertify eLearning module, On-label Promotion, with the content your representatives need to stay in compliance as they interact with HCPs.

Have a great week everyone!

Week in Review, March 6, 2015

A potential new law in California calls for greater drug pricing transparency, consumer advocacy groups and industry trade groups in Europe argue over clinical trial data transparency, a Maine law allowing the purchase of pharmaceuticals from foreign pharmacies is overruled, and the issue of off-label speech and free speech is back in the news.

In like a lion and out like a lamb; it’s hard to believe March is here. The really good news…spring is almost here as well (although looking at the seven inches of fresh snow outside the Week in Review windows, we find that hard to believe). Whether you subscribe to the meteorological or astronomical start of spring, one way or another it is/will be here this month, and that alone is reason to celebrate! We are on the downward slope of winter, folks and we couldn’t be happier. Another thing that makes us happing is sharing the news of the week with all of you, so let’s spring in to action and get this week’s Week in Review underway!

Nothing says spring like some sunshine, and nothing says sunshine like transparency laws. A California assemblyman has proposed a law that would require the disclosure of information related to the pricing of drugs. The law would apply to drugs costing $10,000 or more for a course of treatment, and companies would have to report information such as production costs, sales and marketing costs, and financial assistance provided through prescription assistance programs. If the law is passed, companies would submit annual reports to the state, and the information would be made available to the public.

Speaking of transparency and disclosure, there seems to be a kerfuffle blooming in Europe over clinical trial data transparency. Proposed rules by the European Medicines Authority (EMA) have prompted comments from industry trade groups and others regarding the confidentiality of commercial information. Industry groups have said certain data related to clinical trials could reveal trade secrets and compromise patient privacy. Consumer advocacy groups insist the more transparency the better in the name of protecting patients. In a press release, a Germany-based advocacy group accused the EMA of writing such a broad definition of commercial confidential information that the determination of what is confidential is left up the study sponsor. Two bio industry trade groups released a statement saying there should be a “deferral” for the disclosing information from Phase I trials due to the “commercial sensitivity” of the information.

Medical device manufacturer, ev3, had to spring for some past promotional issues allegedly committed by one of its recent acquisitions. The company agreed to pay $1.25 million to settle allegations that it violated the False Claims Act. The government claimed Fox Hollow Technologies, which was acquired by ev3, caused hospitals to improperly bill Medicare and Medicaid for medically unnecessary inpatient stays for patients undergoing atherectomies using a Fox Hollow device. The government alleged the company suggested the inpatient procedures in order to drive sales of the device to hospitals, thereby causing hospitals to be reimbursed more than they were entitled.

There’s been a late freeze on the Maine law that allows individuals to purchase prescription drugs from select foreign pharmacies. A federal judge has ruled the Maine law is overruled by federal law, which prohibits importing drugs from foreign countries. The decision nullifies the Maine law. The state can appeal if it chooses.

The seeds are being planted for another free speech case involving off-label statements. A federal district court in California is considering a whistleblower False Claims Act case against Millennium Pharmaceuticals in which the whistleblower claims that Millennium and Schering-Plough (now Merck) promoted a heart drug for off-label uses. In a motion to dismiss, Merck argued that the False Claims Act cannot be interpreted to prohibit the truthful, non-misleading exchange of scientific information. In making the argument, Merck sited both the Sorrell v. IMS Health and U.S. v. Caronia cases. The DOJ filed a brief with the court saying that truthful speech could be used as a basis for the False Claims Act. PhRMA filed a friend of the court brief in support of Merck’s argument.

With that, we end this “almost spring, we hope” edition of the Week in Review. Have a great week everyone!