GENERIC SUBSTITUTION FOR DRUGS WITH EXCLUSIVE INDICATIONS

Executive Summary

GENERIC SUBSTITUTION FOR DRUGS WITH EXCLUSIVE INDICATIONS poses no risk to pharmacists of liability or loss of liability insurance coverage, the National Association of Pharmaceutical Manufacturers (NAPM) contended in a Dec. 30 letter to a California-based pharmacy group, Pharmacists Planning Services, Inc. (PPSI). NAPM was responding to a "Generic Alert" memorandum and a subsequent newsletter, which was mailed by PPSI to its members, which warned that pharmacists could face a liability risk for substituting generic propranolol for Ayerst's Inderal, when it is prescribed for post-myocardial infarction patients. Not only do PPSI's views "have absolutely no legal basis," but they were disseminated after the group had been advised that they are "incorrect as a matter of law," NAPM charged. PPSI's assertion was based on the grounds that only Inderal is labeled for the post-infarction indication ("The Pink Sheet" Sept. 30, T&G-5). NAPM demanded an "immediate and complete retraction in a manner that is reasonably calculated to reach all those to whom the original advice was rendered." PPSI's statements that such substitution for Inderal poses a civil liability risk and that liability insurance will not cover such cases are "intended to frighten pharmacists into avoiding substitution of not only generic propranolol, but generic drugs generally," the association maintained. "The only reason" generic propranolol labeling differs from Inderal's is that under the 1984 ANDA/patent restoration law, "certain new indications approved for existing products between Jan. 1, 1982 and Sept. 24, 1984 are available exclusively until Sept. 24, 1986 (two years from the date of passage of the act) for the product" that received the new indication, NAPM explained. "On Sept. 24, 1986, however, all generic propranolol products, without necessitating any change whatsoever in formulation, dosage, strength or manner of manufacture, will be able to" print labels that include the post-infarction indication," the association said. Rep. Waxman (D-Calif.), one of the congressional authors of the ANDA/patent law indicated to PPSI in a Nov. 25 letter that "the information provided in the 'Generic Alert' letter was substantially and significantly incorrect," NAPM said. "In essence," Waxman's letter indicated "that pharmacists did not face increased risk of liability or loss of liability insurance for the dispensing of generic propranolol regardless of the indication for which the drug was prescribed," the association maintained. After receiving Waxman's opinion letter, PPSI issued its newsletter "essentially" repeating the views earlier expressed in the "Generic Alert," NAPM asserted. "In our view the information you are providing regarding the substitution of generic propranolol is disparaging of generic propranolol (and generic drugs in general) and was published and distributed with knowledge that it was incorrect," NAPM said.