This Weekly Roundup did not come soon enough for me! And yet it is hard to believe that the first quarter of 2007 is over. Next week, I’ll do the look back at the Warning Letters for the quarter. But in the meantime, here is what happened this week, a beautiful Spring week here in the Beltway, I might add.
- FDA Announces Voluntary Withdrawal of Pergolide Products – Parkinson’s Disease sufferers take note. Treatment options are fewer here. The FDA announced that announced that manufacturers of pergolide drug products, which are used
to treat Parkinson’s disease, will voluntarily remove these drugs from
the market because of the risk of serious damage to patients’ heart
valves. According to the FDA press release, the products being withdrawn are Permax, the trade name for
pergolide marketed by Valeant Pharmaceuticals, and two generic versions
of pergolide manufactured by Par and Teva. Pergolide is in a class of
medications called dopamine agonists and is used with levodopa and
carbidopa to manage the symptoms (tremors and slowness of movement) of
In 2006, an estimated 12,000 patients received prescriptions for
pergolide from retail pharmacies in the United States. Patients taking
pergolide should contact their doctors to discuss alternate treatments.
Patients should not stop taking the medication, as stopping pergolide
abruptly can be dangerous.
There are alternative therapies available for Parkinson’s disease,
including three other dopamine agonists that have not been associated
with valvular heart disease. The removal of pergolide products is not
expected to adversely affect patient care because of the alternative
FDA Launches Web Page Warning Against Buying Accutane – More bad news for Accutane, there are apparently counterfeit sellers who would take advantage of those in need. The FDA has created a new Web page on Accutane advising consumers against dangers related to purchasing this drug on line.
Dendreon Gets the Nod from Advisory Committee for Provenge - Despite the fact that the two studies that were submitted by the company failed to meet primary or secondary endpoints, Provenge (sipuleucel-T) got a unanimous ok for safety and a 13-4 vote on efficacy from the Cellular, Tissue and Gene Therapies Advisory Committee for demonstrating a survival capacity in patients with advanced prostate cancer. If approved for marketing by the FDA, the treatment would become the first
active cellular immunotherapy and the first biologic approved to treat
prostate cancer. Provenge has been designated fast-track status by FDA.
- Legislation to Reauthorize Pediatric Rule Introduced - Senator Hillary Clinton introduced legislation to reauthorize the pediatric rule this week. The Pediatric Research Improvement Act, legislation that would make
permanent the Food and Drug Administration’s authority to ensure that
drugs marketed for pediatric use are safe and effective for children.
Without action by September 30, the FDA’s authority to require drug
companies to submit pediatric data will expire. The Senator provides YouTube coverage - http://www.youtube.com/watch?v=ASChVaSGk9I
- Senators Kennedy and Enzi to Introduce PDUFA Bill – I am told this will happen today and I will be posting a copy of the legislation under the proposed legislation column on the right side of the blog home page.
That’s it folks. Have a wonderful spring weekend.