New REMS for Avandia restricts access, signaling new way to restrict drugs from market

New REMS for Avandia restricts access, signaling new way to restrict drugs from market

May 19th, 2011 // 11:19 am @

Last September, the FDA decided to allow the controversial Avandia diabetes pill to remain on the market. The move came after more than three years of debate over the cardiovascular risks of the which the GlaxoSmithKline drug and charges that the drugmaker failed to sufficiently disclose clinical trial data showing the magnitude of those risks.

Nonetheless, the agency made clear there would significant restrictions on accessibility to patients who are unable to control their illness by using other meds. For instance, doctors will have to document patient eligibility and patients will have to review statements describing CV safety concerns associated with Avandia and acknowledge they understand the risks.

New Webinar – July 28 – Dangerous Documents: How to Avoid Landmines in Your FDA Documents and Emails
Speaker: Nancy Singer, President, Compliance-Alliance LLC, former DOJ attorney
Save $100 w/Offer Code 59100

Today, though, the FDA announced the Risk Evaluation & Mitigation Strategy, or REMS, for Avandia and there is a provision not previously anticipated. After November 18, patients will no longer be able to obtain Avandia from a retail pharmacy. Instead, patients will have to enroll in a new Avandia access program and the diabetes pill will only be available by mail from a certified, participating pharmacies.

This decision is yet another way to, essentially, minimize usage. Given that there are choices for doctors and patients, Avandia sales will continue to drop. Once a $3 billion seller, Avandia generated $680 million in sales last year. The number of people filling an Avandia prescription fell by 50 percent from 235,500 patients in January 2010 to around 119,000 last October.

In effect, the FDA has clearly signaled that there is more than one way to remove a drug from the market. And in doing so, the agency has also underscored that the REMS program can be more than a laundry list of drugs that require patients to read a medication guide.


Subscribe Now

Testimonial

"ExpertBriefings.com always selects excellent speakers – some of the best I have ever heard. Their messages are direct, clear, timely, and relevant."

Anon A. Mouse

Featured Partner