- FDA recently posted numerous comments from industry regarding Ramipril 180-day exclusivity issues on its website. The comments come in response to FDA's request last month. A summary of the new comments is in the works.
- FDA also established a docket for comments on Granisetron HCl 180-day exclusivity issues. This too follows an FDA request made last month.
- Yesterday, the WSJ Health Blog had two pessimistic reports on the pharmaceutical industry: "Drug Drought Deepens as FDA Approvals Lag" and "Pharma Woes Won't Let Up Soon."
- Also on Halloween, the New York Time published a spooky article entitled "Chinese Chemicals Flow Unchecked Onto World Drug Market." Reuters published a similar article the next day. This can't be good publicity for pharmaceutical companies--both innovators and generics alike--who are increasingly outsourcing production of key ingredients to China.
- On Tuesday, the Federal Circuit denied rehearing of BIO and PhRMA v. District of Columbia, in which the court previously found Washington, D.C.'s drug price control law to be unconstitutional (see Patently-O).
- Last week, Sen. Bernie Sanders (D-VT) introduced a new bill that would scrap patent and market exclusivity for drugs and replace it with a "medical innovation prize fund" (see FDA Law Blog and Pharmalot). I suspect that this bill is DOA, and therefore nothing to fear.
- Also last week, the WSJ Health Blog reported on Amgen's big win in its patent infringement suit against Roche's Mircera drug.
- A couple weeks ago, BioPharma Reporter published an interesting article, "U.S. Dragging its Heels on Biosimilars, Report Says."
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Dear Aaron,
I have put up a very brief summary of all the comments on my blog here:
http://genericpharmaceuticals.blogspot.com/2007/11/ramipril-documents-recd-at-fda.html
Hope you find them a good start.
I know, your analysis as a US Attorney will be much more cogent and focussed.
Sincerely,
Sandeep,
Matrix.
Posted by: Sandeep K. Rathod | November 02, 2007 at 11:21 PM