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Product safety issues for 10 percent of Big Pharma’s total prescription market were among several factors leading to significantly lower- than-expected sales last year.

Although Big Pharma experienced a 3.8 percent sales growth in 2007, representing $286.5 billion in prescription drug sales, the rate of growth was down from 8 percent in 2006, and marks the lowest growth rate since 1961. According to a report from pharmaceutical marketing consultants IMS Health, product safety issues were among the reasons causing the slump.

IMS attributed the drop in sales to these primary factors:

• Loss of exclusivity of branded drugs to generics, which now hold nearly 68 percent of the market
• The fewest new, innovative drugs approved in 3 decades (and slowed physician adoption of new medicines, too)
• Slowing of Medicare Part D prescription drug business as that program matures
• The repercussion from mounting drug safety issues

Safety issues included a significant number of “black box” label warnings, as well as a number of important product withdrawals. The FDA also raised safety concerns about other products in the erythropoietins, diabetes and antidepressant therapy classes. Overall, says the IMS report, safety issues contributed to “significantly lower- than-expected sales, accounting for approximately 10 percent of the total prescription market.”

In his great blog, Eye On FDA, Mark Senak poses some interesting questions about the situation, suggesting that if the drop in product approvals isn’t because of the FDA’s backlog (which are due at least in part to staffing shortages), it could be increased concern over product safety:

“One can truly see one of the many impacts of the fact that the agency has issued more approvable letters in 2007, to a degree shutting down the pipeline, impacting the market, patients and stockholders. This of course, leads to the question whether or not this is a product of (i) a risk averse environment, or (ii) products have suddenly gotten bad, or (iii) the FDA has purposely slowed things down so that it can catch up.”

(“Approvable letters” are notices to drug makers that new products can’t be approved until additional actions are taken, usually in the area of more studies and testing.)

My thoughts are plainly this: Anything the FDA wants to do to beef up and improve testing before approving new drugs is okay with me. And I’m sure with the American public too, who are fed up with all the injuries, deaths and massive lawsuits stemming from incomplete, shoddy and even unethical testing and reporting — not to mention unethical marketing — that for too long has put the protection of profits and investor confidence ahead of consumer protection and confidence.

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