I don’t mind sharing that it has been an exhausting week. So much for the lazy hazy days of summer. Apologies for the missed postings – among other things the week involved travel in messy weather. Here inside the Beltway, we are anticipating the departure of our Congress, sending them home to you while we enjoy a city that for one brief month, is quite pleasant to navigate.
- A Second Approvable Letter Issued for Trexima – In what appears to be an on-going trend to not only approvable letters, but multiple approvable letters, GlaxoSmithKline and Pozen announced that they had received a second approvable letter for Trexima. According to the release, "[i]n January 2007, POZEN and GSK responded to the FDA’s first approvable letter, submitting additional safety data from clinical trials, data from GSK’s database, and additional in vitro preclinical data. In the second approvable letter, no additional information regarding the cardiovascular safety of Trexima was requested. The companies agreed to conduct a prospective study after approval to evaluate the effects on blood pressure during chronic, intermittent treatment." In this letter, "[t]he FDA has requested that POZEN further address the Agency’s concern, prior to approval, about the potential implications from one preclinical in vitro chromosomal aberration study (one of four standard genotoxicity assays) in which genotoxicity was seen for the combination of naproxen sodium and sumatriptan, but not with either component alone. None of the other three standard genotoxicity studies (Ames test, mouse lymphoma TK assay, in vivo mouse micronucleus assay) demonstrated any genotoxicity for the combination of naproxen sodium and sumatriptan. "
- Avandia Advisory Committee Meeting – A joint meeting of the Drug Safety Risk Management Committee and the Endocrinologic and Metabolic Drugs Advisory Committee resulted in an overwhelming vote that Avandia has some cardiovascular issues as well as an overwhelming vote to keep it on the market. The committee felt that they were operating on a lack of data to direct any action otherwise, adding that the product should have increased warnings, which was already in the works.
- FDA, Defense Department Share Data to Enhance Medical Product Safety Reviews – In a release that was quite short on details and meaning, a new program of data sharing was announced between two agencies of the government that have seen their credibility erode over the past several years. The release says that "data" from the U.S. Military Health System will soon help the U.S. Food and Drug Administration make decisions affecting the safety and use of FDA-regulated products for all Americans. But it doesn’t say what kind of data or under what circumstances, only that the two agencies have "announced a partnership to share data and expertise related to the review and use of FDA-regulated drugs, biologics, and medical devices." This includes "general patient data such as prescriptions, lab results and patient weight will be used by the FDA to spot trends, which may identify potential concerns as well as recognize benefits of products." The release assures us that "the two agencies will protect all personal health information exchanged under the agreement, in accordance with federal law." This is according to a memo of understanding that is also short of explanation. Presumably this will help the agency in looking for post-marketing trends in actual use of newly approved drugs.
- FDA Announces Program to Enhance States’ Food Safety Programs – The agency this week launched a national program to bring about the adoption of more uniform, equivalent, and high quality regulatory programs by state agencies responsible for regulating facilities that manufacture, process, pack, or hold food under FDA’s jurisdiction. According to the release, currently, programmatic activities can vary from state to state and such variations can lead to inconsistencies in oversight of food safety. Adoption of voluntary standards for state regulatory programs will establish a uniform basis for measuring and improving the performance of state programs for regulating manufactured food and help the state and federal authorities reduce foodborne illness hazards in food facilities.
That’s it for this week. I, for one, plan on getting some rest this weekend. Hope you do too.