FDA Meets First REMS Deadline

The inaugural REMS class of 2008 was unveiled today and it’s a list of recognizable pharmaceuticals and biologics.

One of the most important premarket and postmarket pieces for biopharma companies of the FDA Amendments Act, signed into law on September 27, 2007, was the authority for the agency to require certain manufacturers to submit and implement a risk evaluation and mitigation strategies (REMS) program.

In essence, these are the risk management plans of old with timetables, a broad spectrum of possible requirements and penalties for non-compliance. The REMS can be as minimal as required labeling and a timetable for re-review of the program itself, or a very rigid, closed-loop, restricted distribution plan.

FDA had 180 days as of the day FDAAA was enacted for the REMS provisions to take effect—March 26. The March 26 notice in the Federal Register means FDA was right on time.

Here’s a few of the most notable drugs to get a REMS: Biogen Idec/Elan’s multiple sclerosis drug natalizumab (Tysabri); Celgene’s multiple myeloma and MDS therapy lenalidomide (Revlimid); Novartis’ schizophrenia drug clozapine (Clozaril); Danco Laboratories abortion pill mifepristone (Mifeprex); and Roche’s severe acne treatment isotretinoin (Accutane) to name a few.

One drug not on the list that caught our attention was Genentech’s allergic asthma therapy omalizumab (Xolair). Genentech had touted Xolair’s risk minimization action plan (RiskMAP) as a stabilizing event back in July 2007. To read our analysis, click here.

So how come no REMS? We asked FDA. The answer: the first list of drugs requiring REMS programs under FDAAA are those with pre-existing risk management plans that have restricted distribution systems. Xolair does not have such an explicit mandate.

More specifically, the Federal Register outlines six elements for drugs deemed to get a REMS plan:

1) Health care providers who prescribe the drug have particular training, experience, or certification;

2) Pharmacies, practitioners or health care providers that dispense the drug are specially certified;

3) The drug is dispensed to patients only in certain health care settings;

4) The drug is dispensed with documentation of safe use conditions, such as lab results;

5) Each patient taking the drug is subject to monitoring; and

6) Each patient using the drug is enrolled in a registry.

To read the Federal Register notice in full, click here.

FDA's timely enactment of the REMS provision shows the agency knows just how closely it is being watched with regards to the implementation of FDAAA and that agency leadership is taking the deadlines set in the law seriously. For biopharma companies, the question remains: how will life change? That one will take time to answer.