GENERIC DRUGS: Losing Battle Against Brand Name Grants
An article in today's Wall Street Journal takes a look at why generic drugs are having so little success in competing against their brand-name counterparts. Despite the fact that "every generic approved by the [Food and Drug Administration] has been found by the agency to be precisely the same chemical, with the same dosage and equivalent absorption rate, and with the same manufacturing consistency that brand manufacturers must have," brand names are still managing to elbow out their less costly competitors. It comes down to muscle: the "pharmaceutical titans" have the funds to deploy an "arsenal" of expensive tactics to promote and ensure market dominance of their products. Generic drugmakers, for the most part, do not.
Direct-to-consumer pharmaceutical marketing costs are an annual $10.8 billion expenditure for brand-name companies, and growing. Patients are advised to "ask their doctor" about a specific drug being promoted. And to prepare physicians for such requests, pharmaceutical companies dispatch armies of salespeople, or "detail people," with free samples to fill physicians' closets. As an example, the Journal cites calcium channel blocker (beta blocker) drugs for heart disease, widely accepted as standard treatment for heart attack patients. Hoechst Marion Roussel's Cardizem CD, at $78 monthly, is up to four times more expensive than its generic equivalents, atenolol and metaprolol, at $21-$36 for a month's supply. But doctors who have been detailed and provided with free samples of the brand- name drug often prescribe these drugs to patients, and when the "freebies in the 'starter kits' have run out, a patient often ends up on long-term, even lifelong, prescriptions for that drug."
A second "platoon" at big pharmaceuticals' dispense are well-paid lobbyists and lawyers, able to go after generics for such "patent infringements" as shape and appearance of the pill itself. In addition, "'citizens' petitions' filed with the FDA to oppose generic drugs -- often filed by citizens who happen to be lawyers for big drug companies" -- can block generics from the market for years, even if the petitions are ultimately rejected by the FDA. Of "[a]t least 40" petitions filed between 1990 and 1997, 24 for were rejected.
The Journal reviews in some depth the example of DuPont's anti-coagulant Coumadin. The FDA approved Coumadin's generic form, warfarin, last year, but despite costing about $7 more per dose, Coumadin so far has retained 80% market share. DuPont has played up Coumadin's designation as a narrow- therapeutic index drug -- "meaning that there is a narrow range of safe blood levels of the drug" -- to try and convince state legislators and agencies "to limit the ability of pharmacists to switch patients to warfarin." DuPont warns patients "should not be switched to another formulation of warfarin sodium without the knowledge or approval of the patient and his or her physician." The FDA came down hard on DuPont in January: "We cannot overstate the seriousness with which we regard DuPont's false and misleading promotion of Coumadin." Nonetheless, DuPont is pushing legislation that would require pharmacists in at least 20 states to secure verbal approval from a doctor before substituting warfarin for Coumadin. An effective roadblock: warfarin's market share in North Carolina, where such phone calls are required by law, is 7.7%. In Wisconsin, where druggists may substitute at will, warfarin's share is 25.3%. Said the FDA's Dr. Roger Williams, director of pharmaceutical science, "You can't call all the physicians. It effectively blocks generics" (Burton, 11/18).