The PharmaCertify™ Team

Is it really that time of year again? The Easter Bunny hasn’t even visited yet! Afraid it is, folks.  Unless you live in Arizona or Hawaii, you’ll be moving your clocks ahead one hour this Sunday for Daylight Savings Time. The extra hour of evening light is little consolation for the loss of one hour of sleep. We won’t let our supreme disappointment (or a solar flare for that matter) stop us from springing forward with the news of the week.

The Pharmaceuticals and Healthcare Association of the Philippines (PHAP) is going to spring ahead with adopting the recently updated Code of Practice from the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). The CEO of PHAP says implementation of the revised Code shows the group’s dedication to building trust with the medical community and patients. All 44 PHAP member companies are expected to follow the Code when it goes into effect in September. The group is encouraging non-member companies to abide by the code as well.

Connecticut physicians are being questioned for being “on the clock” for pharmaceutical companies even after violating the rules. An investigation found a number of physicians disciplined by the state medical board for issues involving their prescribing continued to receive payments for speaking engagements. In one case, the physician continued to receive payments after his license was revoked. Two companies, Eli Lilly and GSK, beefed up their screening process for speakers to include a check to identify if a doctor has been sanctioned by his or her state and Pfizer is exploring the idea of implementing similar state-level checks.

Folks at the University of Rochester Medical Center may have an extra spring in their step since they received a higher grade on the PharmFree scorecard. URMC went from a “C” to a “B” on the yearly scorecard, which rates medical schools and academic medical centers on their conflict of interest policies. URMC made a number of changes to its policies, banning the acceptance of gifts from the pharma industry, and tightening the circumstances by which free samples may be used.

In legal news, a former FDA chemist, Cheng Yi Liang, received a 5 year prison sentence for insider trading. The chemist used his knowledge of drug approvals to play the stock market to the tune of $3.8 million. In a pre-sentencing memo, his lawyers stated Liang was addicted to day-trading. Liang also has a $1.7 million civil judgment against him.

A consumer group and four trade unions have sued 8 pharmaceutical companies to keep the practice of providing drug co-pay coupons from springing along. The groups claim the practice is illegal, and in the long run it drives up the cost of healthcare. Despite the savings the coupons provide the consumer, insurers are still required to pay the negotiated cost for the drug. The use of the coupons forces plans to spend money on brand name drugs over cheaper generic ones.

A bill patterned after the federal False Claims Act has been introduced in Washington to help recoup losses the state suffers due to Medicaid fraud. Despite the state’s budget challenges, the bill has met some resistance from legislators. The Washington State Medical Association fears the bill, which includes whistleblower provisions, will encourage people to file frivolous lawsuits.

A former defense lawyer for the industry is shining some daylight on her belief that the fines imposed on pharmaceutical companies facing charges for illegal marketing are not sufficient to curb the illegal behavior. Frustrated by the fact that negotiated settlements represent a small portion of total profits on the products involved in off-label or false claims cases, the lawyer wrote a 63-page paper suggesting other measures, such as exclusion from federal healthcare programs, or requiring companies to conduct clinical trials for the off-label uses they market. Gregory Demske, assistant inspector general for legal affairs at HHS, says the government has considered other options, including pursuing company executives, and revoking a company’s patent rights as a part of the settlement.

The DOJ has experienced some fall back…er…fall out (yep, that one hour loss of sleep is really weighing heavily on the mind) in its FCPA prosecutions, but they are not the only government agency pursuing companies under the Act. The former chief of the SEC’s FCPA enforcement unit, Cheryl Scarboro, sat down with the folks at TrustLaw for a Q & A about FCPA prosecution. Among the issues discussed are whether the U.S. should publish cases it declines to prosecute and Ms. Scarboro’s thoughts on the Frank-Dodd whistleblower protections.

At a panel session at Georgetown Law, an official from the DOJ says the agency is committed to moving forward in the pursuit of FCPA cases. Saying the agency is in it “for the long haul,” Nathaniel Edmonds, assistant chief of the department’s fraud section, acknowledged the DOJ had some recent setback, but they have learned from those challenges. He believes the challenges were not with the FCPA itself, but rather the specific facts in the cases. When asked about the FCPA guidance due this year, Edmonds declined to comment.

Well, that brings us to the end of another News Week in Review. We hope that despite the loss of one hour of the weekend, you still have a great one and we’ll see you right back here, a little less rested, next week!