The last Weekly Roundup of May! The first BBQ has happened. And sitting on my back deck, the sweet smell of honeysuckle wafts over from the fence. Petunias are in full riot. The basil is standing proudly and already being used regularly with Mozzarella and heirloom tomatoes that I pick up at the Farmer’s Market on DuPont Circle. Memorial Day weekend is upon us – that time when, as a child, signaled a summer liberated from learning…
And here is what happened this week that caught my eye.
- CBO Issues Brief on Banning DTC for Prescription Drug Advertising -This Congressional Budget Office issued a brief this week examining some of the effects that a moratorium on DTC advertising would have on the market, drawing on data documenting direct-to-consumer advertising and other promotional activities used by pharmaceutical producers as well as academic analyses of how advertising has affected the market for drugs. You can see the entire brief here.
- FDA to Make Enforcement and Compliance Activities Accessible Online – As part of its transparency initiative, the agency announced this week that it was opening up a Web portal that would reveal FDA’s enforcement and compliance-related activities more accessible, downloadable, and searchable online. The information on the portal includes a summary of the most common Inspectional Observations of objectionable conditions or practices made during inspections and a searchable Inspections Database that includes the names and addresses of inspected facilities, inspection dates, type of FDA-regulated products involved, and final inspectional classification. By the end of 2011, FDA will also begin to disclose additional information about FDA evaluations of filers, expand disclosure of Untitled Letters, and in appropriate situations, support industry efforts during a food recall to inform consumers of products that are not subject to the recall.
- FDA Approved Vertex’s Incivek for Hepatitis C – Ok can I just say that Incivek sounds like a town in Iceland where you stop before getting to the capital Reykjavík? Ok, but it isn’t a small town in Iceland, it is a big drug. The FDA announced the approval of Incivek (telaprevir) to treat certain adults with chronic hepatitis C infection. Incivek is used for patients who have either not received interferon-based drug therapy for their infection or who have not responded adequately to prior therapies. Incivek is approved for use with interferon therapy made up of peginterferon alfa and ribavirin. The sustained virologic response for patients treated with Incivek across all studies, and across all patient groups, was between 20 and 45 percent higher than current standard of care. Sixty percent of previously untreated patients achieved an early response and received only 24 weeks of treatment (compared to the standard of care of 48 weeks). The sustained virologic response for these patients was 90 percent.When a person achieves a sustained virologic response after completing treatment, this suggests that the hepatitis C infection has been cured.
That’s it for me this week folks. With the passage of Memorial Day, next week I’ll be sporting white bucks and linen – at least till Labor Day do us part!