FDA Official Calls for More Authority Over Prescription Drug Labels
FDA should have the authority to require revisions to the language on prescription drug labels and studies to test the safety of medications currently on the market, a top agency official said on Tuesday at a Senate Committee on Health, Education, Labor and Pensions hearing, the New York Times reports. The committee held the hearing to examine potential reforms to FDA, which has faced increased criticism in recent months over prescription drug safety concerns.
A joint FDA advisory committee last month concluded that the COX-2 inhibitors Celebrex and Bextra, manufactured by Pfizer, can increase risk for cardiovascular events similar to Vioxx, which Merck withdrew from the market in September 2004 over safety concerns. The committee recommended stronger warning labels for all COX-2 inhibitors (Harris, New York Times, 3/2).
FDA last month also announced plans to establish a Drug Safety Oversight Board, which will monitor and report -- on an advisory basis -- information about adverse reactions to medications (California Healthline, 2/16).
Sandra Kweder, deputy director of the FDA Office of New Drugs, testified that, although an agency advisory committee previously had concluded that Vioxx can increase the risk for cardiovascular events, more than one year passed before Merck made revisions to the label of the medication. According to Kweder, FDA and Merck in February 2001 began negotiations on revisions to the Vioxx label but did not reach an agreement until April 2002.
Kweder said that Merck rejected several FDA proposals for revisions to the Vioxx label and that the agency "similarly rejected many of the proposals" from the company. She said, "We don't have the authority to tell a company, 'This is how your label has to look,'" after medications reach the market (New York Times, 3/2). "We had to negotiate with the company how the specific language should be worded," Kweder said (Kellman, AP/Las Vegas Sun, 3/1).
She added, "The lapse from my perspective was the delay that it took to get that information into the labeling" (Rowland, Boston Globe, 3/2). Kweder also said that FDA failed to place information about the potential risks of Vioxx "in the forefront of the consciousness of the prescribing physician" (New York Times, 3/2).
In addition, Kweder said that, although having the authority to require studies to test the safety of medications currently on the market could prove beneficial under "extreme circumstances," the agency already has the ability to prompt such studies in most cases (Wilde Mathews, Wall Street Journal, 3/2).
FDA has "strong authority" over the language on prescription drug labels prior to approval of medications, but pharmaceutical companies are "in a much stronger position" after treatments reach the market, the Boston Globe reports.
According to the Globe, FDA can threaten to begin legal proceedings to remove a medication from the market or ask the HHS secretary to declare a treatment an "imminent hazard," but, "short of those dramatic moves, the FDA's options are limited" (Boston Globe, 3/2).
FDA Office of New Drugs Director Steven Galson after the hearing said that the agency has not requested more authority over the language on prescription drug labels.
According to the Times, "Every witness who went before the panel ... said the agency must do a better job of uncovering" prescription drug safety concerns "using existing computer databases."
Former FDA official William Schultz said the agency should have the authority to limit or ban prescription drug advertising after approval of a medication and to limit some prescriptions to certain specialists.
Former FDA official Scott Gottlieb of the American Enterprise Institute said that the agency "doesn't use its existing authority very well" and that proposals to revise the language on prescription drug labels often "aren't worded very well." He said that such proposals improve after FDA has discussions with pharmaceutical companies (New York Times, 3/2).
HELP Committee Chair Michael Enzi (R-Wyo.) said that he had not yet decided whether he would propose reforms to FDA. Enzi said that many of the witnesses who testified at the hearing agreed on several issues, adding that "there were some indications of some good ideas here" (Wall Street Journal, 3/2). He added, "We must weigh benefits and risks. We should not try to reinvent the wheel and develop a system that aims for an impossible standard of zero risk" (Schuler, CQ Today, 3/2).
Sen. Edward Kennedy (D-Mass.), ranking member of the committee, said that he "looked forward to working closely" with Enzi "on legislation to restore the ability of the FDA to deal effectively with the challenges it faces" (Wall Street Journal, 3/2).
Merck spokesperson Casey Stavropoulos said, "We worked diligently with FDA to do all requested analyses and develop labeling that provided physicians with the most accurate and appropriate information" (New York Times, 3/2).
Pharmaceutical Research and Manufacturers of America spokesperson Jeff Trewhitt did not comment on the remark Kweder made at the hearing, but he said, "We do believe that FDA jurisdiction over product labeling is adequate" (Boston Globe, 3/2).
PhRMA regulatory affairs specialist Alan Goldhammer said that the pharmaceutical industry has not taken a position on whether FDA should have the authority to require studies to test the safety of medications currently on the market (Pugh, Philadelphia Inquirer, 3/2).
According to the Times, testimony at the hearing "could cause difficulties for Merck," which faces more than 800 lawsuits filed by patients who allege that they were injured by Vioxx (New York Times, 3/2).
PBS' "Nightly Business Report" on Tuesday included an interview with Pfizer CEO Hank McKinnell about potential FDA requirements for stronger warnings on the Celebrex label and other issues (Gharib, "Nightly Business Report," PBS, 3/1). The complete transcript is available online.
In addition, C-SPAN's "Washington Journal" on Wednesday included an interview with Goldhammer about the FDA approval process ("Washington Journal," C-SPAN, 3/2). The complete segment will be available online in RealPlayer and Windows Media after the broadcast.