Botox Promotions Investigated
The U.S. Attorney's office for the northern district of Georgia has subpoenaed Allergan, seeking documents that might show off-label promotion of Botox (botulinum toxin type A) for the treatment of headache. The company confirmed the inquiry in a statement, and said that while Allergan currently has Botox in phase III studies for headache, "it is Allergan's policy to promote its products only in a manner consistent with the FDA-approved product labeling." Allergan also intends to comply "with all applicable laws, rules, and regulations," according to the statement. Botox is Allergan's second-biggest-selling product, with $1.2 billion in sales in 2007. The company is projecting sales of about $1.3 billion this year.
Galderma Buys CollaGenex
Two dermatology powerhouses are about to combinethat is, if U.S. regulatory authorities approve the merger of Galderma Laboratories and CollaGenex Pharmaceuticals. Galderma proposes to purchase all of CollaGenex's outstanding shares for about $420 million. Galderma, a subsidiary of the Swiss drugmaker Galderma Pharma based in Newtown, Pa., has such products as Clobex, Tri-Luma, Cetaphil, and Pliaglis. It is also seeking U.S. approval for Dysport, a botulinum toxin type A injection sold in Brazil and Argentina. CollaGenex's flagship therapy is Oracea and the company is testing a vitamin D analogue for mild to moderate psoriasis. Galderma said that it expects to complete the merger before the end of the second quarter.
Supreme Court Limits Device Suits
The U.S. Supreme Court has bolstered medical device manufacturers' argument that FDA approval confers special protection against liability suits. The justices voted 81 in finding that the Medical Device Amendments of 1976 supersede state law. That federal law regulates devices that have gone through the premarket approval process, the most rigorous path to approval. Plaintiff Charles Riegel's estate had sued Medtronic Inc., alleging that a catheter that ruptured during cardiac surgery was designed, labeled, and manufactured in violation of New York law. But the justices said that FDA approval "bars common-law claims challenging the safety or effectiveness of a medical device. …" They upheld two previous lower court decisions; Justice Ruth Bader Ginsburg was the sole dissenter. Members of Congress involved in crafting the original amendments were not pleased. "Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices," said Sen. Ted Kennedy (D-Mass.) in a statement. "Congress obviously needs to correct the court's decision," he said.
Woodcock Named CDER Head
Dr. Janet Woodcock has been named director of the FDA's Center for Drug Evaluation and Research. Dr. Woodcock, a rheumatologist, served as director of CDER once before, in the 1990s, and has served as acting director since October 2007. The drug industry's chief lobbying group, PhRMA, welcomed the appointment. Dr. Woodcock "has demonstrated willingness to work with diverse partners, including researchers, Congress, the White House, patients, and pharmaceutical research companies," said a statement from the group. But Public Citizen's health research group director Dr. Sidney Wolfe said in an interview that he's "not terribly hopeful" that Dr. Woodcock will lead the center well, because she doesn't like conflict or controversy. "I don't think she's the kind of CDER director we need right now," Dr. Wolfe said. "She's aware of a number of drugs on the market that should be taken off the market, but I don't think she has the fortitude to do something about it."
Drug, Device Promotion May Expand
FDA last month proposed draft guidance that would allow drug and medical device makers to distribute medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices. Drug and device makers had been allowed to disseminate such materials under guidelines set by the FDA, but that authority expired in September 2006. The FDA's new "Good Reprint Practices" draft guidance states that the article or reference should be published by an organization that has an editorial board and fully discloses conflicts of interest. In addition, articles should be peer reviewed, and manufacturers should not distribute special supplements or publications funded by product manufacturers. Rep. Henry Waxman (D-Calif.), chairman of the House Committee on Oversight and Government Reform, blasted the FDA for its proposal, which he said in a statement "is great news for the drug industry but terrible for the public health."
Rx Abuse Worries Americans
The abuse of prescription drugs is as big a problem as the abuse of illegal drugs, according to respondents to a Wall Street Journal/Harris Interactive poll. Even so, less than half of those surveyed said they keep prescription medicines in a place where others can't access them. Seventy percent said they were somewhat or very concerned about the risk of addiction associated with some prescription pain medications. The vast majority of the 2,027 adults surveyed voiced the same level of concern about drug side effects and potentially harmful interactions between pain medications and other prescriptions. About 60% of the respondents said they discuss with their physician other prescriptions they are taking when they are prescribed a new medication. Smaller numbers said they told their physician about over-the-counter medications or nutritional supplements.