Acting FDA Commissioner Lester Crawford Discusses Prescription Drug Safety Issues at Senate Confirmation Hearing
Acting FDA Commissioner Lester Crawford on Thursday at a Senate Health, Education, Labor and Pensions Committee confirmation hearing on his nomination as permanent commissioner said that he would consider the establishment of an independent prescription drug safety office at the agency, the Los Angeles Times reports (Alonso-Zaldivar, Los Angeles Times, 3/18).
Crawford has served as acting commissioner or deputy commissioner of FDA for the past three years. President Bush in 2001 considered Crawford for the position of FDA commissioner before he nominated Mark McClellan, who currently is the CMS administrator.
Crawford, who has served as acting FDA commissioner since McClellan left the position last March, has focus on expedited approvals of new medications, protection of the U.S. food and prescription drug supply from terrorist attacks and improvement of prescription drug manufacturing and safety. Crawford has said that he opposes the legalization of prescription drug reimportation from other nations.
During his tenure, critics have raised concerns about how FDA addressed safety issues related to COX-2 inhibitors, reports that antidepressants could increase the incidence of suicidal thoughts in children and an unexpected flu vaccine shortage last year. Most Republicans and the Pharmaceutical Research and Manufacturers of America support confirmation for Crawford. Some Democrats -- as well as Consumers Union, the Consumer Federation of America, the U.S. Public Interest Research Group and Public Citizen -- have questioned his nomination (California Healthline, 3/17).
The committee plans to vote on whether to confirm Crawford on April 13 (Harris, New York Times, 3/18).
Crawford at the hearing "tried to defend the FDA while simultaneously pledging to transform its internal culture," the Los Angeles Times reports (Los Angeles Times, 3/18). He said that FDA remains the "gold standard" on prescription drug safety (Schuler, CQ Today, 3/17). Crawford said, "I don't think we've been tarnished. (But) I promise to you to do everything in my power to stem the tide and do the right thing."
He added that he is "committed to addressing existing concerns regarding postmarket safety of FDA-regulated products, both in medical products and food" (AP/Washington Times, 3/18).
Crawford also said that FDA plans to revise practices used to disclose potential conflicts of interest among members of agency advisory committees (Wilde Mathews, Wall Street Journal, 3/18).
According to the Los Angeles Times, Crawford "could run into stiff opposition unless he can convince senators that he would follow through with changes at the FDA."
In response to questions about prescription drug safety, Crawford said that the establishment of an independent agency office to address the issue "is something I am certainly open to discussing" (Los Angeles Times, 3/18).
Senate Finance Committee Chair Chuck Grassley (R-Iowa) last week announced plans to introduce legislation to establish an independent FDA office to monitor the safety of prescription drugs on the market and warn the public about potential risks. Under the bill, the director of the office would have the legal authority to require pharmaceutical companies to revise prescription drug labels. In addition, the legislation might include a provision that would provide the office with the authority to suspend prescription drug advertising or sales during an investigation (California Healthline, 3/11).
HHS officials in February announced plans to establish the FDA Drug Safety Oversight Board, which will monitor and report information about potential prescription drug safety issues on an advisory basis. Board members will not have authority to remove prescription drugs from the market or revise sale practices for medications, but FDA will make board recommendations available to the public on a Web site (California Healthline, 2/16).
Crawford said that FDA decided to establish the board because agency officials who review applications for new medications might "have an affinity with the drug that probably doesn't look good, at a bare minimum; so, we're going to be making a separation" (New York Times, 3/18). According to Crawford, an independent FDA prescription drug safety office would lack pharmaceutical industry knowledge and experience. He said, "We want to take advantage of staff knowledge. They need to be carefully monitored by me" (CQ Today, 3/17).
After the hearing, Sen. Christopher Dodd (D-Conn.) said, "An independent drug safety office within the FDA ... is a critical step in restoring the public's trust in the phrase 'FDA-approved.'" Sen. Barbara Mikulski (D-Md.) said, "There is a crisis of confidence over drug safety in the public mind and even among some clinicians." She added that an FDA prescription drug safety office "needs to be independent of the whole bureaucracy, reporting only to the commissioner" (Los Angeles Times, 3/18).
According to the Washington Post, the "sharpest questioning" from the committee involved a delay in an FDA decision on whether to allow over-the-counter sales of emergency contraception (Kaufman, Washington Post, 3/18).
FDA in late January delayed a decision on a revised application from Barr Laboratories to allow the sale of Plan B over the counter to women ages 17 and older. Under the application, women ages 16 and younger would require a prescription to receive Plan B (California Healthline, 1/24).
According to the New York Times, committee Democrats said that they will require an explanation about the delay before they voted on whether to confirm Crawford, who said he will provide the information (New York Times, 3/18).
However, Crawford said that FDA likely will not reach a decision on the revised application from Barr before April 13. He said, "The science part is generally done. We're just now down to what the label will look (like). This is going to be a very unusual sort of approval" (Washington Post, 3/18). "I can assure you that this decision will not be based on politics. It will be based on science," he said (New York Times, 3/18).
Sen. Hillary Clinton (D-N.Y.) said, "I am hopeful that we will reverse what appears to be a dangerous slide into political opinion rather than scientific evidence" (Washington Post, 3/18).
Sen. Edward Kennedy (D-Mass.) asked Crawford for his opinion on how FDA addressed safety issues related the COX-2 inhibitor Vioxx, which Merck withdrew from the market in September 2004. Crawford said that the safety issues "could not have been anticipated."
Kennedy said, "I'm trying to detect whether it's going to be business as usual. I'm not sure the American people are going to be satisfied by (Crawford's saying) there are a number of situations that can't be anticipated, and therefore that's the way it should be" (Los Angeles Times, 3/18). Kennedy added, "Disturbing allegations have been raised that FDA has prevented open scientific discussion of important drug safety issues, has disregarded science that conflicts with ideology and has retaliated against whistleblowers" (AP/Washington Times, 3/18).
In response to questions about his position on prescription drug reimportation, Crawford said, "As far as being safe, that worries me a lot." Crawford also said he has worked with NIH officials to establish a registry of clinical trial results. He said, "We have heard the unalloyed message from the public that they want to know about those clinical trials, they want to be able to read about them. So that's a charge to keep, and we will move forward as best we can" (New York Times, 3/18).
Committee Chair Michael Enzi (R-Wyo.) also questioned Crawford about issues related to mifepristone (Washington Post, 3/18).