Top FDA Official Testifies That Agency Requires No New Authority
FDA requires no new authority from Congress to ensure prescription drug safety, Janet Woodcock, acting deputy commissioner for operations at the agency, testified at a Senate Health, Education, Labor and Pensions Committee hearing on Thursday, the Philadelphia Inquirer reports (Pugh, Philadelphia Inquirer, 3/4).
The committee held the two-day hearing to examine potential reforms to FDA, which has faced increased criticism in recent months over prescription drug safety concerns. FDA last month announced plans to establish a Drug Safety Oversight Board, which will monitor and report -- on an advisory basis -- information about adverse reactions to medications. Sandra Kweder, deputy director of the FDA Office of New Drugs, on Tuesday testified that FDA should have the authority to require revisions to the language on prescription drug labels and studies to test the safety of medications after they reach the market (California Healthline, 3/2).
Woodcock on Thursday said that, contrary to previous testimony, the agency does not require studies to test the safety of medications after they reach the market. According to Woodcock, "if there's a need for additional studies, it's going to become apparent" and pharmaceutical companies will address the issue (CQ HealthBeat, 3/3). Woodcock "refused to answer" whether she agreed with Kweder that FDA should have the authority to require revisions to the language on prescription drug labels, the New York Times reports (Harris, New York Times, 3/4).
According to the Inquirer, "Woodcock outranks Kweder, and her testimony, in its timing at least, supersedes Kweder's" (Philadelphia Inquirer, 3/4). Woodcock also said that FDA has decided to increase the frequency and detail of communications with patients and physicians (New York Times, 3/4). She said, "We plan to put information out to the public directly about emerging safety issues. We will be getting information out to people who need it in a timely manner" (Alonso-Zaldivar, Los Angeles Times, 3/4).
Woodcock added, "The steps we've taken to give information directly from the FDA to the public will help deal with some of these problems" (Appleby, USA Today, 3/4).
In addition, Woodcock recommended against the establishment of an agency outside FDA to monitor prescription drug safety, as some lawmakers have proposed, because agency officials have the expertise required to determine the risks of side effects of medications that become apparent after they reach the market (New York Times, 3/4). However, she acknowledged that FDA officials could have an "intellectual bias" toward medications they had approved (Los Angeles Times, 3/4).
Woodcock also said during a break in the hearing that pharmaceutical companies continue to provide physicians with cruises and trips to resorts to market their products, despite promises in 2002 to end such practices, the New York Times reports. Although the American Medical Association recommends that physicians avoid such gifts, Woodcock said that the "abuses" continue and that FDA has no authority to monitor such practices.
Jeff Trewhitt, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said, "If Dr. Woodcock has any examples of violations, we urge her to call the companies involved" (New York Times, 3/4).
During the hearing, Woodcock testified that direct-to-physician prescription drug advertisements have "more impact on doctors' prescribing practices than direct-to-consumer ads" (Rovner, CongressDaily, 3/3). She added that "there needs to be more of a balance" between the risks and benefits of medications in such ads. Trewhitt said that FDA regulations currently require such a balance (New York Times, 3/4).
However, Woodcock said that disclaimers about risks in prescription drug ads "aren't sinking into people's consciousness." She added that some physicians write unnecessary prescriptions based on direct-to-consumer prescription drug ads, which she called a "double-edged sword." Woodcock said, "Doctors say it improves communication with patients. But in some cases, there may be increased awareness of drugs, while people don't have a full understanding of the risks" (Japsen, Chicago Tribune, 3/4).
Raymond Woosley of the University of Arizona testified that the practices FDA uses to monitor the safety of prescription drugs fail to "detect serious adverse effects of products until they are on the market, often for years, and millions of Americans have been exposed to potential harm." Woosley said that FDA should first approve new medications only for limited populations and for use to treat specific conditions and later allow broader use (Los Angeles Times, 3/4).
In addition, Woosley said that FDA should reduce the period required to test experimental medications from 12 years to four years but should require tests to continue after approval of treatments. In response, Trewhitt said, "The existing drug approval process is thorough and already evaluates both drug safety and effectiveness. His proposal is complex, and it does not appear it would speed up drug approvals or improve drug safety" (USA Today, 3/4).
Bruce Psaty, a professor of medicine and epidemiology at the University of Washington, testified that more than 1,000 employees in the FDA Office of New Drugs "work to review a few dozen new drugs per year," adding, "In the Office of Drug Safety, 109 employees work to evaluate the safety of thousands of drugs currently on the market." Psaty also said that the structure of FDA is "just what the drug industry desires: a powerful engine to approve new drugs and a weak effort to investigate safety in a post-marketing center" (New York Times, 3/4).
He called for a new FDA Center for Drug Safety with broad authority over medications after they reach the market. "If manufacturers do not address the potential risks and benefits with equal scientific rigor, the FDA must insist they do so, both before and after approval," Psaty said (Los Angeles Times, 3/4).
After "weeks of neutrality," committee Chair Michael Enzi (R-Wyo.) on Thursday indicated that recent internal reforms at FDA "did not do enough to protect patients" and that he would "explore options for bipartisan legislation" on agency reform, the Los Angeles Times reports (Los Angeles Times, 3/4). Enzi said that "doing nothing to address the current controversies is not an option" (New York Times, 3/4). He added that he would seek a "comprehensive response" to FDA reform supported by "both sides of the aisle." Enzi said he has discussed an FDA reform bill with Sen. Edward Kennedy (D-Mass.), ranking member of the committee, and Sen. Chuck Grassley (R-Iowa), who has criticized the agency in recent months.
Kennedy called on Congress to increase funds for the FDA prescription drug safety office and provide the agency with the authority to require revisions to the language on prescription drug labels after they reach the market. Enzi said that he opposes the establishment of an agency outside FDA to monitor prescription drug safety, a proposal supported by Grassley (Los Angeles Times, 3/4). Kennedy also said that direct-to-consumer prescription drug ads "almost certainly" encourage "unnecessary use" of medications (Chicago Tribune, 3/4).
Sen. Richard Burr (R-N.C.) said that current practices used by FDA to monitor prescription drug safety are a "1950's model for registry that we have never changed to reflect not only what technology can do but what physicians have time to do." Burr added, "All suggest we need a more robust post-approval surveillance process" (New York Times, 3/4).
As "part of a concerted effort by the FDA to take a tougher stance on drug advertising," Kathryn Aikin of the agency Division of Drug Marketing, Advertising and Communications on Thursday told a conference of 400 prescription drug marketing executives that FDA plans to develop new voluntary advertising guidelines for pharmaceutical companies, the Boston Globe reports.
Aikin, who spoke on the third day of the DTC National annual conference, said, "Consider this a heads-up. We are very concerned about the direction consumer advertising seems to be taking." She added, "The ads really need to lean more on the educational side. It is important to reconsider the way you are presenting risk information in consumer ads."
According to the Globe, some executives at the conference said that they would "welcome specific FDA guidance on how to present risk information" (Rowland, Boston Globe, 3/4).
In other FDA news, Kweder last week in a letter said that the Cancer Letter violated ethical guidelines with the publication of the names of five candidates for director of the new agency Office of Oncology Drug Products. In the letter, Kweder said the Society of Professional Journalists guidelines on ethics state that "(o)nly an overriding public need can justify intrusion into anyone's privacy," adding, "We see no overriding public need to speculate about the status of possible candidates involved in this job search."
She added that "(w)e were disappointed to see a detailed report in the cancer letter ... that included uncorroborated names of possible candidates." Kweder said that the report could delay or undermine FDA efforts to fill the position. Kirsten Boyd Goldberg, editor and publisher of the Cancer Letter, dismissed the letter from Kweder. The five individuals named in the Cancer Letter report were Richard Pazdur, director of the FDA Division of Oncology Drug Products; Patricia Keegan, director of the agency Division of Therapeutic Biological Oncology Products; Karen Weiss, director of FDA Office of Drug Evaluation VI; Charles Schiffer of the Barbara Ann Karmanos Cancer Institute; and John Marshall of the Vince Lombardi Cancer Center (Kaufman, Washington Post, 3/4).