Over the weekend, President Barack Obama nominated Margaret Hamburg to serve as the new commissioner of the Food and Drug Administration (FDA) and Joshua Sharfstein to serve as principal deputy commissioner of the agency.
The FDA regulates about a quarter of all the consumer products that Americans buy, which roughly equals $1 trillion. Many analysts predict that Hamburg and Sharfstein will divvy up their functions in the agency with Hamburg focusing chiefly on food issues and Sharfstein being charge of drugs and medical devices. What should we expect?
To some extent, their priorities can be discerned from statements greeting their nominations to the FDA. Many activists who have been fierce critics of the agency issued highly favorable assessments of the two nominees. For instance, Michael Jacobson, head of the Center for Science in the Public Interest (which calls itself the "food police") hailed their selection. Jacobson called Hamburg "forward thinking," which should "enable her to return the FDA to its role as a trusted, effective regulatory agency." Jacobson praised Sharfstein for eliminating trans fats from Baltimore's restaurants.
Jean Halloran, Director of Food Policy Initiatives at Consumers Union predicted that Hamburg will provide "the leadership it needs at a time when it faces huge challenges." Ellen Bloom, federal policy director for Consumers Union, added that Sharfstein is "just what the doctor ordered for FDA." The Consumer Federation of America (CFA) welcomed both Hamburg and Sharfstein, calling their resumes "extremely impressive." The CFA added, "We hope that these talented and caring individuals will bring a new era to the FDA."
On the other side of the equation, some industry representatives were a bit less enthusiastic. For example, the Pharmaceutical Research and Manufacturers of America issued a press release praising President Obama's "expeditious selection" of Hamburg, while passing over Sharfstein's appointment in decorous silence.
Both have impressive resumes. Hamburg is a former health commissioner in New York City who served as assistant secretary of Health and Human Services during the administration of President Bill Clinton. She now works at the think tank Nuclear Threat Initiative, a non-profit organization focused on reducing the public safety threat from chemical, biological, and nuclear weapons. Sharfstein is a former staffer for Rep. Henry Waxman (D-Calif.) and the current Baltimore health commissioner. Sharfstein made a name for himself by challenging the safety of cough medicines for children.
In his announcement, Obama focused on food safety issues. A lot of media attention has been devoted to stories about spinach contaminated with E. coli bacteria and peppers and peanuts tainted with salmonella. However, the most recent data from the U.S. Centers for Disease Control do not find a significant change, either up or down, in foodborne illnesses in recent years—although such illnesses are down appreciably from 10 years ago. Of course, that record could be improved, and Hamburg and Sharfstein have strong credentials in this area.
Both industry representatives and activists believe that the way the FDA regulates pharmaceuticals and medical devices needs to be reformed. But they strongly disagree on how. Industry would like to get new medicines to the bedsides of patients faster, while activists want to slow down that process in order make sure that medicines are safe.
In welcoming Hamburg and Sharfstein, Bill Vaughan, a Consumers Union health analyst, declared, "The American medicine cabinet has become a little shop of horrors. In recent years, the agency has been too slow to protect consumers and too willing to give industries a pass on safety." What Vaughan means is that he and other activists believe that the agency approves drugs too fast and takes too long to withdraw "dangerous" ones.
In response to the barrage of claims from activists and their supporters in Congress that hasty action by the FDA endangers the public, agency approval of new drugs has been on a downward trend since the 1990s. In 2007, the FDA approved only 19 new drugs, the lowest number since 1983. Last year saw an uptick to 24 new medicines. Part of the reason for this drug drought is that since the 1980s the FDA has doubled the number of clinical trials and tripled the number patients required for approving a new drug. This has boosted the cost of getting a new drug past cowed regulators from about $250 million (in constant dollars) in the late 1980s to over $1 billion today. But perhaps these more stringent requirements have improved drug safety? Not really.
A 2005 report by the Tufts University Center for the Study of Drug Development found that faster approval times do not correlate with increased drug safety withdrawals. In fact, the percentage of drugs withdrawn for safety reasons in 1980-1989 was 3.2 percent, rising slightly in 1990-1999 to 3.5 percent, and falling in 2000-2004 to 1.6 percent. In addition, approval time for drugs that are withdrawn is not appreciably shorter than the average approval time for all drugs. The good news is that the FDA snatches dangerous drugs from the market much sooner than it used to. The average time between FDA approval and subsequent safety withdrawal dropped from 3.7 years in the 1980s to 1.4 years in the 1990s and is now 0.7 years.
Sam Kazman, the general counsel and head of the Death by Regulation project at the Competitive Enterprise Institute, a free market think tank, opines, "Hamburg overall has pretty good credentials." He adds, "The question is does she see FDA overcaution as a big problem or does she see problems elsewhere?" With regard to Sharfstein, Kazman says, "I am much less optimistic given Sharfstein's past association with Henry Waxman."
Sharfstein's ties to Waxman are indeed worrisome. Waxman, head of the House Energy and Commerce Committee, which oversees legislation dealing with the FDA, has a vast backlog of projects he wants to impose on the agency. These include banning direct-to-consumer advertising for new drugs for two years, extending FDA regulatory authority over tobacco products and dietary supplements, creating a separate federal food safety agency, and forbidding pharmaceutical companies to supply physicians with medical journal articles describing off-label uses of drugs. Off-label refers to the use of a drug to treat a condition for which it has not been officially approved by the government. This practice is legal and common and has thus far been seen as appropriate by the FDA.
The ban on advertising and restrictions on off-label information will leave patients and physicians ignorant about the benefits and risks of medications. The FDA is supposed to regulate the safety of foods and medical drugs. Tobacco, of course, is neither, and everyone knows that while it pleasurable to use, it is not healthy to smoke or take snuff. With regard to dietary supplements, consumer education rather than increased regulation is the way to go. And finally, creating a federal food safety agency could have advantages, but food agency bureaucrats might become as risk-averse as FDA regulators currently are. In advancing Waxman's extensive FDA agenda, the signs point to Sharfstein becoming the congressman's hand puppet inside the agency.
"The big question is will Hamburg and Sharfstein treat any unexpected side effect of a new therapy as evidence that the FDA is falling down on its job?," asks Kazman. He adds, "The only way to guarantee zero unexpected side effects is to have zero new therapies."