FDA Has Done ‘Spectacular Job’ With Public Safety, White House Chief of Staff Andy Card Says
FDA has done a "spectacular job" in efforts to protect the public and has met the "expectation of improving health care," White House Chief of Staff Andrew Card said Sunday on ABC's This Week, the AP/Raleigh News & Observer reports (AP/Raleigh News & Observer, 12/19). Card made the comments after he was asked whether he supported a call from Sen. Chuck Grassley (R-Iowa) call for an investigation of FDA similar to that conducted by the Sept. 11 commission.
Card said, "I don't know that we need a commission," adding, "I've got great confidence in the FDA." In addition, Card said that recent news about previously unaddressed safety risks related to medications currently on the market serves as "a testament to the FDA in how they do their job" (Kaufman, Washington Post, 12/20).
However, Sen. Edward Kennedy (D-Mass.) -- ranking member of the Senate Health, Education, Labor and Pensions Committee -- said that the FDA record "on protecting us from harmful prescription drugs is a catastrophic failure." Kennedy said in a statement, "We need an FDA that looks out for the health of patients and not just the health of the pharmaceutical industry. Lives are at stake, and the president should put an FDA leadership team in place right away, with no ties to the industry in regulates, and that's committed to reform" (AP/Raleigh News & Observer, 12/19).
He added, "Early action on bipartisan FDA reforms is possible in Congress, and I hope that the White House and congressional leadership will not stand in the way" (Washington Post, 12/20).
Many observers have said that the "absence of settled leadership has become a significant problem" for FDA, as the agency has lacked a permanent commissioner for almost two-thirds of the time since President Bush took office, the Post reports. According to observers, FDA in some cases cannot "respond quickly and effectively to emerging problems and has been weakened in the face of political, industry and sometimes consumer pressures to stray from the agency's science-based public health mandate," the Post reports.
White House spokesperson Trent Duffy said that FDA acting Commissioner Lester Crawford has done an "excellent" job and has all the "authorities and responsibilities" of a permanent commissioner. In addition, Duffy said that the White House has no timetable for the appointment of a permanent FDA commissioner.
However, Arthur Levin, director of the Center for Medical Consumers and member of the FDA advisory committee on prescription drug safety, said, "Not having a permanent commissioner doesn't send a good message. Bureaucracies have a life of their own and need to feel their work is a high priority. But not having permanent leadership means you're not a high priority."
Paul Light, a professor at New York University who works on the presidential appointments initiative at the Brookings Institution, added, "There are some in the administration and in the industry who would rather have vacancies at FDA than an aggressive regulator. The theory is that it is better to have no one there than someone who favors a proactive stance that might slow down the industry or raise hard questions about profitable drugs" (Kaufman, Washington Post, 12/19).
According to the Wall Street Journal, other problems at FDA have resulted because "laws that govern the FDA's powers ... were written decades ago, for a different industry." Daniel Troy, former chief counsel to FDA, said the agency operates on a "red light/green light statute" and that a medication "is either approved as safe and effective under the conditions on the label or it isn't" (Wilde Mathews/Martinez, Wall Street Journal, 12/20).
A Knight Ridder analysis found that the United States in 2003 accounted for the first sales of 60% of new medications -- those with active ingredients never previously marketed -- compared with 3% in the early 1980s. In addition, the number of adverse reactions to medications in the United States increased by 145% between 1994 and 2003, although the number of prescriptions filled increased by only 59%, the analysis found.
Former FDA Commissioner and Stanford University professor emeritus Donald Kennedy said that the increased number of adverse events has resulted in part because of problems with the system used by FDA to monitor the safety of prescription drugs currently on the market. He added that the European "(monitoring) system would have picked up a problem earlier than ours would have ... because (Europeans) are better than us -- way better" (Pugh/Borenstein, Knight Ridder/Albany Times Union, 12/19). "There are conspicuous, and perhaps irredeemable, deficits in what we can know about a drug before it is approved," Kennedy said, adding that "you have to be very careful about the introduction of a drug because your ability to deal with it after it is on the market is sharply limited" (Wall Street Journal, 12/20).
According to Sean Hennessey, a University of Pennsylvania professor of pharmacology and epidemiology, the FDA database of adverse events consists of anecdotes because few physicians or patients report problems.
Steve Galson, FDA acting director of the Center for Drug Evaluation and Research, said that "we have to have a robust post-approval program" to detect adverse events after medications reach the market to ensure public safety (Knight Ridder/Albany Times Union, 12/19).
Catherine DeAngelis, editor of the Journal of the American Medical Association, said, "The FDA is broken and needs to be fixed. We're certainly not alone in believing it."
Grassley, who plans to introduce legislation next year to establish a public registry for clinical trial results and separate the Office of Drug Safety from the Office of New Drugs at FDA, said, "At this point, no one can say with confidence whether the worst drug safety problems are behind us or ahead of us. Given these problems, it seems the time has come for a comprehensive review of drug safety and of how federal government agencies oversee drug research and approve, license and regulate drugs."
Jeff Trewhitt, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said that "by and large, the current system is working. ... It is not at all clear to us that there is a need for change." He added, "There are more than 10,000 medications on the market and in the vast majority of cases, they are safely treating patients" (Hughlett, Chicago Tribune, 12/19).
USA Today on Monday in three articles examined recent safety concerns about some medications currently on the market. Headlines appear below.
- "Approved Drugs That Have Researchers Concerned" (USA Today, 12/20).
- "Can Americans Trust Their Medicine?" (Rubin, USA Today, 12/20).
- "Some Answers for Users of Celebrex" (USA Today, 12/20).
Several broadcast programs reported on the Celebrex finding's implications for FDA:
- ABCNews' "World News Tonight": ABCNews Medical Editor Tim Johnson discusses the Celebrex findings and FDA's role in drug safety (Johnson, "World News Tonight," ABCNews, 12/17). A related ABCNews story is available online.
- ABCNews' "This Week": The program includes an interview with David Graham of FDA's Office of Drug Safety (Stephanopoulos, "This Week," ABCNews, 12/19).
- CNN's "Lou Dobbs Tonight": The program includes an interview with Grassley about reform for FDA (Dobbs, "Lou Dobbs Tonight," CNN, 12/17). The complete transcript is available online.
- CNN's "House Call": The program includes an interview with Dr. Brian Strom, chair and director of the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania, about the FDA approval process (Gupta, "House Call," CNN, 12/18). The complete transcript is available online.