A Record Year for the FDA

Regulators have taken much of the blame for the drug industry’s monumental problems, especially their inability to bring new products to market, leaving the US lagging behind many other countries. Now the FDA is fighting back.  The Agency just announced that it green-lighted 30 new drugs in 2011 – a 7-year high.  Among these, Johnson & Johnson  and GlaxoSmithKline received approval for three new drugs each.  FDA Commissioner Margaret Hamburg also noted that it had been the first regulatory authority worldwide to give the nod to a number of novel treatments including  as Seattle Genetics lymphoma drug Adcetris. One possible reason for the increase in new drug approvals was the Agency’s willingness to meet with pharmaceutical companies before data were submitted.  Another may be the industry’s focus on submitting better data, particularly in regard to drug safety.  “I think people have realized that FDA has gotten more difficult and they’re improving what they turn in,” says Citigroup analyst Yaron Werber. Even so, the pharma industry is expecting some tough years ahead with increased generic competition for many of the top-selling drugs. And it remains to be seen whether the industry and the FDA can stay with the 2011 pace for approvals or whether they will sink back to the low numbers experienced in years past.

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