The PharmaCertify™ Team
The thrill of victory, (US Women’s soccer team), the agony of defeat (Aly Raisman and Catalina Ponor both finding themselves out of a bronze medal due to gymnastics’ tie break rules) as well as the human drama of athletic competition (Oscar Pistorius and the first Saudi female athletes), has played out in London as the Olympics came to a close this weekend. And shockingly it ended without an overload of Miley Cyrus’ “Party in the USA” from the broadcast team at NBC. Something to be thankful for! Now it is time to return to the grind. If you’ve been glued to your computer for the around the clock, live stream, we’ve got your back with the News Week in Review.
In the Olympic spirit, an international group of researchers conducted a study regarding the disclosure of conflicts of interest in medical journals. The researchers targeted articles published by physicians and scientists that were reportedly involved in off-label marketing activities. The group found that one in seven authors fully disclosed their conflict of interest. Of the articles reviewed by researchers, only 15% contained adequate disclosure. Researchers are concerned because journal authors may have a strong influence on the prescribing habits of other physicians considering an off-label therapy.
Not defeated but most likely in some agony, KV Pharmaceutical filed for bankruptcy. The company’s CEO said the company has not realized the full value of its most important drug because the FDA has not enforced KV’s marketing exclusivity on the product. Since the exclusivity has not been enforced, several state Medicaid programs have made access to the drug more difficult.
Forest Labs has received another yellow card, in the form of an untitled warning letter, from the Office of Prescription Drug Promotion at the FDA, for statements made by two of its sales representatives. According to the letter, the representatives failed to communicate the drug’s appropriate patient population as well as its limitations of use. In addition, the reps allegedly minimized the risks associated with the product. The OPDP is especially concerned because the company is already under a CIA.
A law firm in Hong Kong has issued a report indicating that more Asian countries are joining in the anti-corruption game. While the FCPA and UK Bribery Act remain the top dogs in driving anti-corruption reform, individual countries are increasingly enacting their own anti-corruption laws. The group found that while the laws are similar in structure, enforcement varies from country to country.
And speaking of anti-corruption, there was certainly a whirlwind of enforcement activity last week. First on the podium is Fresenius Healthcare AG, the world’s largest provider of dialysis equipment and services. The company notified the SEC and DOJ it was conducting an internal investigation into possible violations of the FCPA. Next up, generic drug maker Teva says it has received a subpoena for documents related to its business practices in Latin America. Teva is cooperating with the feds and has hired independent counsel to conduct an investigation. Rounding out the anti-bribery “awards,” Pfizer announced FCPA settlements with the government for over $60 million. The company’s subsidiary, Pfizer H.C.P. Corporation, agreed to pay $15 million to resolve an FCPA investigation and will enter into a Deferred Prosecution Agreement with the DOJ. Pfizer H.C.P. admitted to paying $2 million in bribes to government officials in Russia, Bulgaria, Croatia and Kazakhstan. The DOJ says self-disclosure and cooperation led to a reduction in the base fine and the company is not required to hire a corporate monitor. Apart from the subsidiary settlement, Pfizer Inc. and Wyeth negotiated settlements totaling $45 million with the SEC, to resolve civil FCPA charges.
Well, that brings us to the end of this week’s Review. We’ll be going through a bit of Olympics withdrawal this week without the nail-biting competition, or of course, those awesome interactive Olympic-themed Google Doodles! On the up side though, we can finally look forward to a good night’s sleep. That television coverage to midnight and beyond is a killer! Time to get back to normal, and that includes keeping an eye on the news for all of you. Have a great week everyone!