FDA considering changes to risky drug safeguards
Safeguards to protect patients from risky drugs should have less paperwork and more consistency, drugmakers and pharmacy representatives said this week during a U.S. Food and Drug Administration meeting.
The drug industry acknowledged the benefit of so-called risk evaluation and mitigation strategies, or REMS, a set of disclosure and educational tools to protect consumers from drugs with potentially serious side effects.
But it is requesting a lighter regulatory touch. The FDA said it would consider some changes.
"There has to be obviously the most appropriate balance between protecting the safety of patients, which is of the utmost concern, but also doing so in a way that doesn't cause unnecessary burdens and inefficiencies in the health care system," Jeffrey Francer, assistant general counsel for the Pharmaceutical Research and Manufacturers of America, said on Wednesday.
Patient medication guides that list a drug's risks are the most common type of REMS. With more dangerous drugs, that would otherwise be rejected or taken off the market, companies have to train prescribers or even track patient health.
The tools took effect in 2008 and have been mandated for more than 120 drugs.
Speakers at the two-day hearing called for more transparency on REMS decisions, feedback earlier in the drug development process and equal restrictions on similar drugs.
Nayan Acharya of Eli Lilly and Co said that the burdensome evaluation of REMS should be limited to the riskiest drugs, excluding those that only need a medication guide.
"In place of this one-size fits all approach, we believe that patients and the stakeholders in the health care system could benefit if the FDA were to adopt a more tailored approach to REMS," Acharya said on Tuesday.
There is no timeline for finalizing any changes, but adjustments could come soon for certain drugs, said Jane Axelrad, associate director for policy in the FDA's drug evaluation unit.
"We'll be looking at our program to see whether some of the suggestions that we've heard can be incorporated into REMS that are under development, into new REMS," Axelrad said.
Jon Lentz, Reuters 28-07-2010
Consort Health