FDA Issues New Guidance On How Drug Risk Plans Should Be Modified

Federal drug regulators have issued new guidance for pharmaceutical companies on how to change risk mitigation plans for medications that are so dangerous special steps are required to ensure patient safety.

The guidance (PDF) was issued by the FDA this week, to allow companies to make minor changes to these plans more quickly. 

A number of drugs currently approved by the FDA are subject to a “risk evaluation and mitigation strategy” or REMS. These drugs are deemed medically necessary, but the FDA has acknowledged that they carry higher-than-usual risks. As a result, drug makers are required to provide detailed plans on how patient safety will be maintained.

In many cases, these plans include significant limits on who can be prescribed the drug and may require doctors undergo special training before they can prescribe the medications.

The FDA has released a guide for how drug companies can go back and make changes to those plans once they have already been put into place. The agency first issued a draft guidance on REMS in 2009, two years after the program was initiated.

Originally, companies had to undergo an application process known as a prior approval supplement (PAS), which took months for the FDA to review. The FDA is still requiring a PAS for major changes, but now the FDA is saying that it will review minor changes within 60 days.

The FDA is classifying the changes as either revisions or modifications. Revisions are things such as typographical errors, changes in the company’s address, and other corrections.

Revisions can be done via annual reports, but minor modifications can be done using a CBE-30 supplement. If the FDA has not responded to a CBE-30 request in 30 days, the company can go ahead with the changes.

The guidance details which modifications are considered major or minor and requires the company to detail in their submissions details of the changes and why they need to be made. They must also detail all changes made to the REMS since it was first approved.

The new guidance was required by the 2012 Food and Drug Administration Safety and Innovation Act.