Washington Editor

WASHINGTON - FDA Commissioner Margaret Hamburg last week said she had created a new task force charged with providing recommendations about how the agency can be more transparent about its activities and decision-making.

The task force helps fulfill the agency's obligation under President Obama's pledge for more openness and public participation in government, Hamburg told reporters during a media briefing.

She noted that the FDA has been criticized as being a "black box," where important decisions are made without explaining them to the public.

"While the agency cannot disclose all types of information, I believe the agency can do a better job of providing useful information to the public in a timely manner," Hamburg said. "The agency can and should communicate with the public in a way that provides more clarity about agency activities and processes, not less."

Providing information to the public in a timely user-friendly manner, she said, is "critically important" to restoring the agency's credibility with the public.

The transparency task force is being led by Joshua Sharfstein, the agency's principal deputy commissioner, and consists only of high-level FDA officials.

However, Hamburg said the task force will base its recommendations on input from the public and industry, which the group plans to gather through a series of meetings, public comment and from responses on a blog posted on the agency's website.

The first public meeting is set for June 24 in Washington, with a second meeting to take place sometime in the fall, Sharfstein told reporters. The agency is accepting public comments until Aug. 7, he noted.

The task force also is reaching out to FDA employees to obtain their input, Sharfstein added.

Regulators want to hear from the public, industry, health professionals and internal employees specifically about whether the FDA should provide more information on enforcement actions, product approvals, recalls and other regulatory activities and how best to convey that information, such as whether the Internet is the best venue.

In addition, regulators are seeking advice on what, if any, legislative or regulatory changes are needed to improve the FDA's ability to provide useful and understandable information to the public.

The FDA also is seeking recommendations about what should be kept confidential, and in such cases, how best to explain why regulators are keeping such information from public view.

The task force is expected to submit a written report to Hamburg within six months, Sharfstein said.

FDA Reveals More Drug Safety Concerns

The FDA last week released its latest list of drugs and classes of medications being evaluated by regulators for potential safety problems, which included Cephalon Inc.'s sleep disorder drugs Provigil (modafinil) and Nuvigil (armodafinil).

The quarterly reports, presented in a table format on the FDA's website, were mandated by Congress under the FDA Amendments Act of 2007 and are based on adverse events reported to the FDA from prescribers, consumers and manufacturers.

The agency earlier had released lists in September 2008 and February 2009. (See BioWorld Today, Sept. 8, 2009, and Feb. 6, 2009.)

Regulators have stressed that the appearance of a drug on the list does not mean that the FDA has concluded that there is a causal relationship between the medication or drug class and the suspected safety issue. Rather, it means that the agency is analyzing adverse event reports to determine whether there is a safety problem and if any further regulatory action is needed.

Cephalon already has updated the labeling for Provigil and Nuvigil with alerts about the potential for serious skin rashes, such as Stevens-Johnson syndrome. However, the FDA said in the new report that it was continuing to evaluate the drug for the reactions to determine whether further regulatory action is needed.

Baird & Co. analyst Thomas Russo said the FDA likely included Nuvigil and Provigil on its list this time because "we are in an era of increased disclosure from an FDA that does not want to be accused after the fact of not disclosing inconclusive safety signals."

Among other drugs, the FDA's list also included Merck & Co. Inc.'s HIV drug Isentress (raltegravir), which recently had its labeling updated to alert prescribers and patients about adverse psychiatric events, and EMD Serono Inc.'s fertility treatment Ovidrel (choriogonadotropin alfa), for which regulators had received reports of anaphylactic reactions.

FDA: Liver Injury Gene Found

The FDA and the International Serious Adverse Event Consortium (SAEC), a nonprofit research group that is funded by the pharmaceutical industry and the Wellcome Trust and receives consultation and guidance from the FDA, said last week that new study results have provided insights into the mechanism of drug-induced liver injury (DILI) and have the potential to help identify patients at an increased risk for the serious event.

Several drugs have been linked to liver injury in a small subset of patients, which in rare cases has led to acute liver failure. Although the exact mechanisms behind such rare and unpredictable DILI is unknown, research suggests a genetic contribution, U.S. regulators said.

The SAEC scientists and their academic collaborators have identified the genetic link associated with liver injury in patients taking flucloxacillin, an antibiotic used mostly to treat staphylococcal infections, which is widely used in Europe and Australia but not available in the U.S.

The researchers found that the HLA-B*5701 genotype was associated with flucloxacillin-related liver injury after analyzing DNA samples and DILI genomic data, the FDA said. HLA-B is one of a number of highly variable genes responsible for immune function on chromosome 6. In addition to HLA-B*5701, variations on chromosome 3 were also found to influence risk for DILI.

"These findings provide the research community with novel genomic data on DILI events and make an important contribution to the science of drug safety," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

Lead investigator Ann Daly, professor of pharmacogenetics at Newcastle University, said the study was aimed at ensuring that commonly prescribed drugs are used more safely.