FDA BLA approvals rose in 2009 while NMEs stumbled

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The Food and Drug Administration approved 17 new molecular entities and seven biologics license applications in 2009. That's a substantial improvement in large molecule approvals – the agency granted just three BLAs last year – and a slight downturn in new chemical compounds, from last year's 21 NMEs.

The new biologics included: Centocor/Ortho's TNF blocker Simponi and psoriasis treatment Stelara; Novartis' Ilaris, for the rare auto-immune disease CAPS, and Extavia,for MS; Ipsen Biopharm's cosmetic filler Dysport, GSK's Arzerra, for chronic lyphocytic leukemia; and Dyax Corp.'s Kalbitor, for a rare genetic disorder that causes painful swelling.

Six of the 2009 NMEs and BLAs approved were classified as priority review drugs – those that appear to “represent an advance over available therapy,” while most of the rest were designated “standard” reviews, for those that seem to have therapeutic qualities similar to already marketed products. Priority drugs included: Novartis' Afinitor, for advanced renal cell carcinoma, Coartem for malaria and Ilaris for CAPS; Sanofi Aventis' Multaq, for atrial fibrillation; Lilly's blood thinner Effient; and Lundbeck's Sabril, for seizures.

FDA classified nine reviews as "priority" in 2008.

Meanwhile, warning letters issued by the agency's Division of Drug Marketing, Advertising and Communications rose slightly in 2009 to 13, over 2008's 11, while the number of the somewhat less-serious untitled letters issued leaped to 28 in 2009 from 10 in 2008.

Arnie Friede, a former top Pfizer lawyer and expert on FDA law, saw a "back to basics" approach reflected in DDMAC's enforcement actions.

"There was a continued emphasis of the need for 'substantial evidence,' in terms of adequate and well controlled investigations as defined by FDA regulations, to support advertising claims," said Friede. "DDMAC adhered to its strict interpretation of risk disclosure requirements, as requiring immediate adjacency to benefit claims, particularly in the context of sponsored links. The May 2009 draft guidance on risk disclosure in medical product advertising largely codified the comprehensiveness of DDMAC's view of risk disclosure requirements. At the same time, the November hearings on social media revealed a willingness on DDMAC's part to hear industry's side of the story.

Also of note in 2009, said Friede, DDMAC solidified its relationship with State Attorneys General.  

"Anyone who is under the lingering impression that a Warning Letter has no implications beyond its own terms hasn't been paying much attention to this connection," said Friede, "nor have they been paying attention to how important FDA compliance correspondence has become in civil and criminal enforcement action by the Department of Justice and the Office of Inspector General of the Department of Health and Human Services, in private party consumer fraud litigation, and in State AG consumer protection investigations and settlements."

For 2009, FDA provided a tally of NME and BLA approvals through the end of June. MM&M filled out approvals for the second-half using data from the agency's Drugs@FDA site
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