Pharma and Phraud

Here's a report from Public Citizen summarizing the recent trend in payments by the pharmaceutical industry of civil and criminal monetary penalties. It seems that pharma has now eclipsed the defense industry as the leading defrauder of the US government under the False Claims Act. Some of the report's findings:

In the last twenty years, pharma firms have made 165 settlements for $19.8 billion in penalties. Three-quarters of these (both in terms of numbers of settlements and in terms of fines paid) have occurred in the last five years. GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough accounted, together, for more than half of the twenty years' penalties. Illegal off-label promotion of drugs has triggered the largest number of federal fines. Overcharging state Medicaid programs triggered the largest state-level fines. Actions initiated by industry whistleblowers gave rise to 67 percent of payouts over the last decade.

The report concludes that fines are probably not sufficient motivation to get high-profit-margin firms to behave. It recommends the application of the "Park Doctrine" to pharma executives--a doctrine under which individual executives can be convicted of criminal misdemeanors based on corporate misbehavior, even if they weren't personally aware of the problem. The doctrine is designed to motivate executives to become pro-active in preventing their firms from engaging in criminal misconduct.

The report's call for the FDA to revive the long-neglected Park Doctrine in fact follows recent signals from the FDA that it intends to do just that. The law firm of Hyman, Phelps and McNamara has an informative powerpoint presentation on the FDA's past and future use of the Park doctrine, here. The clear message from the FDA has been, "Expect some prosecutions of pharma executives soon!"

US Restricts Antibiotics in Animals

From the "it's about time" department: the New York Times reports that the FDA is restricting the use of cephalosporins in livestock feed, in order to slow down the development of antibiotic-resistant bacteria. (Recent studies have shown that such resistant bacteria are indeed passed from feed animals to human beings.) Cephalosporins are a class of antibiotic widely used to treat strep, pneumonia, UTIs, skin infections and childhood bacterial infections. Europe banned the use of several antibiotics important in human medicine in 1998; banned the use of all antibiotics for growth-enhancement of livestock in 2006; and has recently moved to ban all prophylactic use of antibiotics in feed animals.

Freelance Sperm Donor

Here's an interesting story: a San Francisco bay-area engineer is being told by the FDA that he has to stop giving away his sperm to infertile couples. The FDA objects to the fact that the donor is not getting a blood test prior to each donation, as required by federal regulations. The donor, who promotes his free service on the web, decided to donate to couples on his own rather than through a clinic because he wasn't interested in payment for donation, wanted to give away his sperm for free, and didn't want the donor anonymity offered by clinics. He's interested in the possibility of playing a role in the lives of his children--which may keep him busy in the future, given that he's fathered 14 since 2007.

Morning-After Pill: Contrasting News

President Obama defended HHS Secretary Sebelius's decision yesterday to override the FDA's recommendation that morning-after contraceptive pills like Plan B be made available over-the-counter to women and girls of any age. Critics were accusing Obama of having directed the override in order to avoid controversy during the upcoming election. Obama today said that he wasn't in on the decision, but that he approved of it, "as the father of two daughters." As a result of the override, the drug will remain behind pharmacy counters, available without a prescription only to women over 17 years of age. Proponents of the FDA's plan saw its main advantage in putting the drug out on the pharmacy floor, where sexually active women could easily locate it, rather than in making it available to young girls; one expert observed that "not many 11-year-old girls" go into drugstores to buy anything, let alone single pills that cost $50.

Meanwhile in the UK the British Pregnancy Advisory Service is offering to make morning-after pills available free to women over 17 via post, after a preliminary telephone interview with a nurse ensures that they understand the pill's use. The charitable organization, which is the UK's largest abortion provider, is urging women to stock up in advance of the holidays, when unwanted pregnancies occur with higher-than-average frequency. The pills are sold online and in pharmacies to girls and women over 16, and are widely available, free of charge, in doctors' offices and NHS clinics.

Plan B Availability Blocked by Sebelius

FDA Commissioner Margaret Hamburg has just released a statement on the FDA's plan to allow the emergency contraceptive Plan B to be sold over-the-counter to women and girls of all ages. FDA found the drug safe and effective for emergency contraceptive use, over-the-counter, for all women and girls of child-bearing potential. But then--this morning--came the politics. From Hamburg's press release:

"[T]his morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential. Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved. Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today. Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17."