FDA Update
Contaminant in Chinese Heparin Controversy Identified by FDA
The substance that contaminated Baxter International blood-thinning drug heparin was identified by Food and Drug Administration officials on March 19 as over-sulfated chondroitin sulfate which is not approved for use in medicine. The announcement came from Dr. Janet Woodcock, acting director of the FDA's center for drug evaluation and research in a conference call with reporters. ``It does not appear to have come straight from the pig,'' Dr. Woodcock said of the contaminant in a report from Bloomberg News. ``It doesn't appear to be a natural contaminant that got in there. We don't know how it was introduced or why.'' She further noted that the substance, usually taken orally as a dietary supplement to treat joint pain, was “chemically modified to act like heparin.”
This latest development in the Chinese heparin contamination scandal, which has already claimed at least 62 lives as of April 8 and resulted in hundreds of adverse reactions in consumers according to an FDA release, has raised concerns among both Members of Congress and the FDA itself. Both groups are working to examine both the overall issue and begin to craft legislative and regulatory remedies to bolster the ability to ensure the safety of imported drugs. The FDA announced in March it plans to place eight staff members in China to ensure safety of food and drugs by 2009. Meanwhile, key Congressional leaders are working on the issue and are now focused on the bill sponsored by Rep. John Dingell (D-MI). The bill, the Food and Drug Import Safety Act of 2007, would amend the Federal Food, Drug, and Cosmetic Act to require new fees on imported food and drugs, additional research on the development of tests and sampling methodologies for use on imported food, and would deem a food, drug, or device to be misbranded if its labeling fails to identify its country of origin. This bill will likely serve as the vehicle for additional efforts to strengthen drug safety and prevent repeats of these incidents. Finally, two oversight hearings on the heparin issue and the private and public response to it are scheduled for late April in the House Energy & Commerce Committee.
Von Eschenbach Says FDAAA Implementation Hurt by Lack of Resources
FDA Commissioner Andrew von Eschenbach told a gathering of food and drug lawyers that the agency is struggling with ambiguities and a lack of resources as it works to implement the sweeping new Food and Drug Administration Amendments Act of 2007 (FDAAA) passed last summer. According to a report in the March 26 National Journal, Von Eschenbach lauded the FDAAA for the “new authorities and drug-industry user fees it granted the agency but bemoaned other unfunded provisions that are causing FDA to reshuffle its deck.” Specifically, the commissioner said a provision that requires FDA to respond to petitions regarding generic drug approval at a much speedier pace will pose problems. "In order to meet that deadline, this will require effort, or additional effort, but the legislation did not come with additional resources for that additional effort, so as a result, FDA has to reprioritize within existing resources and risk not meeting existing or current responsibilities," he said on March 26 at the 51st Annual Food and Drug Law Institute Conference.
The provision applies to petitions brand drug companies typically file when a generic drugmaker seeks approval of a low-cost copycat of the brand. The overhaul measure requires FDA to respond to the petitions in 180 days, a timeframe von Eschenbach called "a substantial decrease" from the agency's average response time. National Journal further reported that FDA is “moving steadily on other provisions in the bill, including one of the highlights of the legislation aimed at better balancing the agency's focus on approving drugs with consumer experience with drugs once they are commercially available.”
FDA Uses New FDAAA Authority to Order REMS for Specific Drugs
A new provision of the Food and Drug Administration Amendments Act (FDAAA)of 2007 has already been put to work for consumers as the agency had just issued a notice ordering submissions of risk evaluation and mitigation strategies (REMS) for specific drug products. This announcement from FDA Chief Counsel Gerald Masoudi came at a March 26 speech to attendees at the Food and Drug Law Institute's Annual Conference in Washington according to a report in BNA Daily Executive. The official notice appeared in the March 27 Federal Register.
According BNA, the notice states that FDA is “identifying certain drugs and biologics, and notifying holders of applications for such drugs that they must submit a proposed REMS by September 21, 2008 and FDA is developing guidance on the preferred content and format of a proposed REMS. The REMS program replaces FDA's former RiskMAPs (risk management action plans), which used marketing limits as part of mitigation strategies.
FDA Opens Hearings on Regulating Stem Cell Therapies
The push for the Food and Drug Administration to set up the rules governing clinical trials for genetic therapies for humans could take a major step forward on April 10-11 as an FDA advisory board meets to debate the design of how these tests will be conducted. The meetings outside Washington, D.C. are “the first step towards clinical trials," said Laurie Zoloth, professor of medical humanities and bioethics at Northwestern University in an April 10 report from CNN Money. "It's an important moment. And it's only the very beginning." The biotech industry and investors want more certainty about the FDA's guidelines for the complex approval process ahead, and assurance that the FDA isn't averse to approving embryonic-stem-cell therapies for political reasons.
However, critics of using human embryos in research still note their opposition to destroying human embryos at the earlier stage of human life to harvest cells and point toward other options such as harvesting them from umbilical cord blood or adult tissue, or "reprogramming" adult cells to behave like stem cells, as demonstrated in recently-released but early-stage studies. These critics still have a powerful ally in the White House as President Bush vetoed a bill in 2007 that would have expanded federal funding for embryonic-stem-cell research beyond limits he approved in 2001.