Today FDA released two documents to assist in assessing and communicating risk in FDA regulated products. The first is a strategic plan that some have noted contains recommendations that are three years old. The Associated Press reports:
“The agency says it will begin studying public response to its announcements on potentially dangerous food and drugs. The plan posted online takes its cue from a 2006 report by the nonprofit Institute of Medicine, which found the FDA needed to do a better job communicating with the public.”
It should be noted that FDA has a very different leadership now than it did in 2006 and that Dr. Hamburg, the new FDA Commissioner, was only confirmed five months ago. Its nice to see that FDA now seems to be on the job. The announcement from FDA states:
“The plan defines three key areas–FDA’s science base, its operational capacity and its policy and processes – in which strategic actions can help improve the FDA’s communication about the risks and benefits of regulated products. The plan also identifies over 70 specific actions for the FDA to take over the next five years, including 14 that the agency commits to accomplishing over the next year.”
The second document is a draft guidance document on Risk Evaluation and Mitigation Strategies (REMS). This will become a very important factor in drug and biologic approvals and REMS will soon become a household acronym. The publishing of the draft guidance opens a 90-day public comment period. There should be a lively discussion among industry and consumer advocates. In its announcement FDA says:
“The U.S. Food and Drug Administration today announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies or REMS, which are required for certain drugs or biologics.
The Food and Drug Administration Amendments Act of 2007 (FDAAA) granted the FDA the authority to require the submission and implementation of a REMS if the FDA determines a REMS is necessary to ensure that a drug’s benefits outweigh its risks.
REMS components include medication guides; patient package inserts; a communication plan for health care providers; elements to ensure safe use including requirements for those who prescribe, dispense, or use the drug; and a timetable for REMS submission.
UPDATE: Not everyone is thrilled by FDA’s focus on risk evaluation and mitigation. Forbes reports that FDA took too long to approve a Sabril, a drug for epilepsy and seizures, because the Agency determined that a REMS was necessary. Here’s what they say:
“The FDA finally convened its panel in January 2009, and the panelists voted unanimously that Sabril should be approved both for babies with infantile spasms and for adults who had run out of options. In February, Lundbeck, a Danish drug maker, bought Ovation for $900 million. The press release announcing the deal trumpeted that Sabril was in the final stages of FDA review.
But Sabril needed a Risk Evaluation and Mitigation System (REMS), FDA jargon for a plan that ensures drugs are only used when benefits outweigh risks. One division was uncomfortable with the measurements on the dosing syringe in which the drug was given, and even after the review seemed close to done, a team of lawyers had to go over it. Sabril was finally approved in August.”