Pharma

FDA drug approvals up slightly in ’09: MedCity Morning Read, Jan. 6, 2009

The early numbers suggest that the Obama-era FDA is perhaps not as tough on the industry as drug companies had feared — or as industry critics had hoped.

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Highlights of the important and the interesting from the world of health care:

FDA drug approvals up slightly in ’09: Sure, it was only up by one, to 26 in 2009 from 25 the prior year, but the U.S. Food and Drug Administration did approve more new drugs in the first year of the Obama administration than the last year of the Bush administration. Of the new drugs, seven were of the biotech variety and 19 were traditional small-molecule drugs, the Wall Street Journal’s Health Blog reports. One analyst suggested that greater funding to the FDA could spell positive things, at least in regard to sped-up approvals, for drug companies. “Better funding of the agency is going to mean that there are fewer delays,” he told the Journal.

Further, last year the FDA added 31 new or updated “black box’’ warning labels to drugs already on the market, down from 56 the prior year. Taken together, the numbers imply that perhaps industry concerns over tougher Obama administration policies towards drugmakers were overblown, the Boston Globe suggests. So perhaps the Obama administration is friendlier to drug companies than was once suspected, which would certainly be good news for the industry, though perhaps not exactly music to the ears of critics of too-cozy ties between the FDA and the industry it oversees.

The Journal has a roundup of some of notable new-drug approvals here.

The most profitable drugs: The fine blog Pharmalot lists the 10 drugs with the biggest pretax margins, courtesy of a Sanford Bernstein analyst. As Pharmalot notes, “A big drug may only account for 10 percent of a company’s total sales, but its contribution to pretax profits could be twice as large.” As we hear more and more about expiring patents, these drugs figure to become increasingly important to Big Pharma (assuming their patents aren’t expiring, too). No. 1 on the list: Pfizer’s depression and anxiety drug Effexor.

Antidepressants don’t help those with moderate depression: Speaking of profitable anti-depression drugs, new research that shows antidepressants likely provide little or no benefit to people with mild or moderate depression likely wasn’t greeted with cheers and high-fives in the boardrooms of Big Pharma. The research, published in the Journal of the American Medical Association, shows that discussing the symptoms of depression with a doctor is likely of greater benefit to such patients, the Los Angeles Times reports. Patients suffering from severe depression do benefit from the drugs, however. No word on whether pharmaceutical executives will be suffering from mild or severe depression if and when this research results in a hit to their companies’ profits.

“There is no doubt that there are tremendous benefits from antidepressants, as our study showed,” the study’s senior author said. “But this study helps us resolve, to some degree, the question of how much benefit people can expect from the medicines themselves when symptoms are not severe.”

11 pages of not-so-light reading: Politico.com has published a document prepared by Senate and House committee staffers that details differences between the two chambers’ health overhaul bills. It may not be particularly light reading, but Washington Post blogger Ezra Klein calls it “by far the clearest and most comprehensive comparison I’ve read.”