BMJ: PDUFA, Speedy Marketing Spread Risks of New Drugs
The faster a drug is approved the more likely it is to be withdrawn or have safety warnings added later, according to the author of a study in the British Medical Journal. In addition, the rapid rollout of mass marketing plans increases the risk that large numbers of patients will be quickly exposed to unknown risks, the study says. The study's author, Dr. David Kao of the University of Colorado Health Sciences Center, told Reuters:
The closer to deadline that a new drug is approved, the more likely it is to later need strong safety warnings or to be withdrawn, he noted ... "It's probably not helping drug safety," Kao said.PhRMA, the U.S. drug industry's lobby group, criticized Kao's theory, saying:
"Unfortunately, the paper published today by the British Medical Journal suffers from a number of flawed assumptions, among the most glaring that Food and Drug Administration (FDA) deadlines for approving drugs have shifted the Agency's focus away from patient safety.Merck's Vioxx is an example of how speeded-up approvals under the Prescription Drug User Fee Act -- which allows companies to get drug approvals done faster if they pay a fee -- has cut approval times, while marketing exposes new drugs more quickly to new audiences. Says Reuters:
Merck & Co Inc's anti-inflammatory drug Vioxx, or rofecoxib, had been tried by 20 million patients before it was withdrawn in 2004 because of its heart dangers.Kao cited Merck's Januvia, or sitagliptin, a diabetes drug, as an example of how fast marketing can follow approval, and spread use of a new drug:
"The FDA approved sitagliptin 3.8 years after the drug's discovery; this compares with five years for rofecoxib [Vioxx] and an industry average of 14.2 years between 1990 and 1999," Kao wrote.
"The product Web site was functional within 90 minutes of approval, and within eight days, Merck had reached 70 percent of target doctors and made first deliveries of sitagliptin to pharmacies. Within 14 days, discussions were completed with managed care organizations covering around 188 million patients or 73 percent of the insured U.S. population."Kao said he was not implying that Januvia will endanger any patients. Rather, he believes that companies should use their newfound abilities to reach patients quickly to monitor use of their drugs in the post-marketing context:
"It is an example of great marketing ... Those techniques could be used for post-marketing surveillance too."PhRMA was annoyed by the article:
It is erroneous to conclude that marketing plays a dominant influence on which medicines physicians prescribe. Marketing is only one of many factors that impact which remedies are prescribed to patients. For instance, payers use multiple tools -- including health plan formularies, tiered co-pays and prior authorization -- that strongly influence which medicines patients ultimately receive.