FDA Begins Posting Safety Review Findings Online

The U.S. Food and Drug Administration (FDA) just started posting online the results of safety evaluations for recently approved medications and vaccines, the Washington Post just reported.

The move comes after a 2007 law mandating the agency to give consumers and health professionals increased information, said the Washington Post. According to the law, said the Washington Post, evaluations must take place 18 following a new drug’s appearance on the market.

Sometimes, unusual and significant side effects are only realized after a drug has been exposed to a larger and more diverse population, outside of the clinical trial environment, the Washington Post noted. This so-called “post-market” analysis looks at an array of data including, patient and physician reports of problems, emerging studies, information from the pharmaceutical industry and from prescription databases, and from experience with the medication in other countries, explained the Washington Post.

Although information will not be posted for every product receiving agency approval due to the many product similarities among products in use—but will be posted on drugs with new chemical make-ups (known as “new molecular entities”), “new biological substances (such as vaccines and monoclonal antibodies), and old drugs approved for new uses or new target populations,” wrote the Washington Post. Earlier this week, the FDA posted synopses of 26 reviews on its Website, and plans on posting new information quarterly, for a total of about 100 annually, according to Robert M. Boucher, a physician in the agency’s pharmacovigilance division. Information on drugs approved prior to September 27, 2007 will not be posted.

Meanwhile, consumer advocates and critics of the current ways in which drugs make it to market have been calling for more transparency into approval processes. Most recently, Reuters reported that potential changes to such processes could incorporate transparency, broaden disclosure, and provide the public with a view into the details of critical FDA decisions.

“The FDA would make substantially more information about the regulatory process available to the publics should the proposals be accepted, said FDA Deputy Commissioner Joshua Sharfstein and Afia Asamoah, director of the transparency effort, reported Reuters, citing the New England Journal of Medicine.

The FDA Transparency Task Force which includes the agency’s leading attorney and scientist as well as the heads of its drug, device, and other centers recommended that the FDA disclose letters to companies to explain its reasons for declining a product or for refusing to accept an application for a new drug or device, said Reuters. The letters are known as complete response or not approvable and refuse-to-file letters, are only released should a company opt to make them public, explained Reuters.

Last year, we wrote that in an effort to improve operations and ease consumer concerns, the FDA announced the creation of the task force to develop recommendations for enhancing the transparency of its operations and decision-making processes. Of note, under the previous administration, the agency was long accused of being corrupt and for a wide variety of issues, conflicts, and failures.

Last year, FDA Commissioner Margaret A. Hamburg, M.D., said that President Obama has pledged to strengthen our democracy by creating an unprecedented level of openness and public participation in government. I have asked the Transparency Task Force to deliver recommendations to me for ways to make more information available and foster better understanding of decision-making.

For more information, check out how vaccine injury lawyers can help with your case