Giving the FDA more power may be the only way to address manufacturing problems that are leading to steady increases in cancer and nutritional drug shortages, the Government Accountability Office concludes.
The Wall Street Journal's health blog previews the report, which blames manufacturing problems including lapses in quality and supply disruptions of raw materials for much of the shortages. Such lapses have led, in part, to a tripling of the shortage of crucial cancer drugs and nutritional products, the GAO report notes. Overall, injectable drugs and generics have been hit the hardest. But cancer, endocrine and nutritional drugs shortages have jumped the most over the last three years, the GAO found.
Companies such as Ben Venue Laboratories and Johnson & Johnson ($JNJ) are among those facing manufacturing and supply problems. As FiercePharma reported in November, the contract drugmaker had to suspend production of J&J's cancer drug Doxil over equipment and quality control problems. As of last month, 2,700 patients were on a waiting list for the drug.
The investigators concluded that regulators are limited by not having the power to make drug manufacturers notify the FDA and the public about shortages. They're also unable to make manufacturers "take certain action to prevent, alleviate or resolve shortages," GAO investigators wrote. If the agency knows about potential shortages, it can help reduce their impact, for example, by allowing the U.S. to import approved drugs from overseas. FDA even has the power to ensure drugs reach consumers from companies who have had quality problems. That's as long as the companies fix the issue before the drugs reach consumers. (FDA has issued an interim order requiring drug companies to report any manufacturing problems)
What happens to this report, however, is a separate issue. Democratic Sens. Tom Harkin, Richard Blumenthal and Robert Casey Jr. commissioned the report, according to the WSJ. Democrats have long argued that the FDA needs beefing up. Republicans don't see things the same way. They've long seen the agency in its current form as hampering drug development and innovation, and have been pushing to revamp the agency to make it more "business-friendly." And as we all know, a divided Congress hasn't exactly been able to accomplish that much.
- here's the WSJ Health Blog story
- read the WSJ's additional drug shortage (sub. req.) piece
- here's the FDA interim rule announcement
Special Report: Top drug shortages by treatment category
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