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A lot of news has been coming from the Food and Drug Administration lately. And that’s almost never good news for the pharmaceutical business.
The FDA recently has taken a number of regulatory actions against drug companies on matters ranging from marketing of unapproved drugs, to pulling unsafe drugs from the market, to drug advertising.
In one recent case, the agency issued a warning to pharmaceutical companies about ads on Web search engines that it deemed misleading and misbranded because they allegedly did not properly link information about the drugs’ efficacy with risks to safety.
In another, the FDA ordered nine drug makers to stop manufacturing and distributing unapproved opioid drugs, many of which have been on the market since decades before current drug regulations were adopted.
And on Wednesday, the agency and Genetench announced that the psoriasis drug Raptiva (efalizumab) would be pulled from the market by June 8 over concerns that emerged in February that its use could lead patients to develop progressive multifocal leukoencephalopathy, a deadly viral infection of the brain. European regulators removed it from the market there as soon as the concerns arose.
With the withdrawal of Raptiva, which already happened in Europe in February, Genentech – recently acquired by Roche – will lose a drug that generated $108 million in sales last year, according to Genentech financial data. Companies like Boehringer Ingelheim and Mallinckrodt can’t continue making or marketing certain opiate-based painkillers until they get FDA approval, causing them to lose sources of income as well. And the FDA’s requirement that such companies as Pfizer, Eli Lilly & Co., Johnson & Johnson and Cephalon take down the ads in question, means fewer patients will be asking their doctors about what the companies’ drugs can do for them.
Overall, an increasingly assertive FDA could mean a decrease in top-line pharmacy sales growth as the agency subjects drugs to more scrutiny before they reach the counter, or even long after they’ve reached it.