FDA: To Ease ‘Off-Label’ Use Restrictions
The Food and Drug Administration announced Friday that it will allow drug and medical-device companies to give doctors clinical data about "using products in ways not specifically approved by the" government. The Wall Street Journal reports that these so-called "off-label" uses had been legal until the FDA Modernization Act passed last year, which barred companies "from giving health professionals clinical studies or other research that would show them new applications for their products" that had not yet been approved by the FDA. According to Jeff Trewhitt, spokesperson for the Pharmaceuticals Research & Manufacturers of America, the new rules are "another way to make sure as many doctors as possible have this important information."
A New Phen-Fen?
Consumer groups decried the FDA decision. Larry Sasich of Washington-based Public Citizen said, "(Consumers) become part of an uncontrolled experiment where no one is keeping track of ... who's helped and who's hurt." As an example of the dangers of off-label use, Sasich pointed to the pairing of drugs that created "phen-fen," the diet pill that gave some patients "a deadly lung disease and heart-valve disorders." The FDA counters that the new rules, expected to be final this fall, require manufacturers "to submit a copy of the information" to the agency for approval "60 days before sending it out" (Hopkinson, 6/8).
Drug Advertising Pushes Limits
The New York Times reported Sunday that "a bold new experiment in directly marketing prescription drugs on TV" has met with growing disapproval from the Food and Drug Administration. The agency has "found problems with" 11 of the 22 drug advertisements that have aired since the agency relaxed its advertising restrictions for the industry last August. Companies responded to the rule change by buying "a record number of campaigns, both in print and on television." However, the FDA says the ads often exaggerate the drugs' effectiveness while downplaying side effects. Consumer advocates contend that the "sales pitches for prescription drugs often offer false hope and encourage people to march into their doctors' offices to demand prescriptions for drugs they know almost nothing about." For physicians, the ads are a "personal affront ... proof that pharmaceutical executives see them as nothing more than highly paid prescription writers." The FDA has so far taken a "wait and see" attitude on the ads, but if drug industry executives continue to "stretch the FDA's rules," the newfound advertising "freedom may not last", the Times reported (Morrow, 6/7).