Well, the government didn’t shut down today. The way that it was covered in the media, the fact that Congress and the Administration averted a shut down by agreeing to a two-week Continuing Resolution, you would have thought they really achieved a major breakthrough. Instead, they merely kicked the can down the road until the 18th of March. Good thing to keep your eye on the can, from an FDA perspective, to see what nets out. In the meantime, we edge close to Spring and are only 8 days away from Daylight Savings Time, my favorite day of the year.
Here is a little bit of what I thought interesting from the week:
- FDA Removes Warning from a Label – It seems rare as hen’s teeth, but it does happen. In fact, sometimes an entire Black Box Warning is removed. Today Gilead Sciences announced that after reviewing post-marketing data, the FDA was lifting a portion of the boxed warning regarding the possibility of liver injury for the drug Letairis (ambrisentan), indicated for pulmonary arterial hypertension (PAH). Patients who are on the drug will no longer be advised to get monthly liver function monitoring tests.
- Complete Response Letter for Oral MS Agent – EMD Serono announced this week that it had received a Complete Response Letter for its NDA for an oral version of Cladribine Tablets for the treatment of multiple sclerosis. Efficacy seems assured, but the company said the agency has asked for additional safety and risk/benefit perspective, either through new studies or through additional analyses of existing data.
- New COPD Drug Approved – On the other hand, the agency did issue an approval letter this week to Forest Pharmaceuticals for its COPD drug Daliresp (roflumilast). The company stated that the compound is first-in-class and that it is the first and only selective phosphodiesterase-4 (PDE4) inhibitor approved for the treatment of COPD. The company stated that it expects Daliresp to be available to wholesalers in the second calendar quarter of 2011.
- FDA Does Not Issue Internet and Social Media Guidance – Again. As more and more social media platforms emerge, such as Quora, and increasing numbers of people turn to the Internet for healthcare information, there is a continued silence from DDMAC on the issuance of a draft (and partial) guideline. For many years, industry has waited for information on the Internet, to no avail, and in the era where social media has become ubiquitous to communications, there has been a need for the agency to provide a point of view of what is permissible and what is not in this burgeoning arena and how to address the many situations where current guidelines fail to inform. The agency continues to say that the guidance will come during the first quarter. They must be busy – they have only issued three regulatory action letters so far this quarter.
- Wall Street Journal Slams FDA for Slow Pace in Approvals for Cancer – In a lengthy and well-constructed criticism, this week the Wall Street Journal took the FDA to task for its approach in approving cancer treatments, citing the case of pixatrone NDA for the treatment of non-Hodkins lymphoma. The drug’s maker, Cell Therapeutics, received a complete response letter and is appealing the decision. It is a piece well worth reading for a number of reasons, including learning about this category and issues associated with the status of Accelerated Approval.
That’s it for me this week. Have a wonderful weekend everyone.
