Mr. Fromson is a Partner with Finkelstein & Partners, LLP, and participates in the firm’s litigation regarding pharmaceuticals.
Drug companies who manufacture and sell generic drugs reap the profits from selling the bioequivalent versions of their counterpart brand name drugs; but they want to avoid responsibility when a victim of their generic drug seeks compensation for a side effect about which the company failed to warn. Since their position has been rejected in lower federal appellate courts, they have appealed to the Supreme Court. Generic drug companies contend their safety labeling must mimic the labeling of the brand name drug by law and so from their perspective, they contend they can’t warn for any risk not already included within the brand name drug’s labeling. Under the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments), a drug company can submit an abbreviated new drug application (ANDA) to the FDA in which it demonstrates the drug is the bioequivalent (i.e., a generic) of the brand name drug already approved. This process allows the generic drug company to avoid the time and expense of providing independent clinical evidence of the drug’s safety and efficacy. Their role in providing less expensive, generic versions of a brand name drug play an obvious and important role in our healthcare system. However, the responsibility to individuals who ingest their drugs, while relying on the adequacy of their labeling, should be shouldered by the very same drug company that has affirmatively decided to place such drugs into the marketplace. Generic drug companies appealed to the Supreme Court in three cases (Actavis v. Mensing; PLIVA Inc. v. Mensing; and Actavis v. Demahy). In each case, the generic drug companies argue that state lawsuits in which individuals claim they failed-to-warn of dangerous side effects should be preempted (superseded) by federal law, thus preventing their lawsuits from going forward. As referenced above, the Hatch-Waxman Amendments do set forth specific regulations which require the generic drug’s labeling to mimic the brand name drug’s labeling for which it is being sold as a bioequivalent. The Obama administration, via the United States Solicitor General’s Office, already submitted an amicus brief in November 2011 in which the Solictor General pressed the Supreme Court to deny review of the issue. “The court of appeals correctly rejected petitioners’ contention that respondent’s failure-to-warn claims are categorically preempted . . . and its decision is consistent with the decision of the only other court of appeals to address the question since Wyeth v. Levine (S.Ct 2009)”, said the Solicitor General in its briefing to the Supreme Court. No Preemption, Contends the U.S. Solicitor General In its 24 page brief, the Solicitor General (SG) acknowledged that the “FDA has consistently taken the position that an ANDA holder may not unilaterally change its approved labeling.” However, the SG referenced numerous ways in which generic drug manufacturers have accountability through obligations that do not conflict with the traditional rule that their labeling must mimic the brand drug. The SG pointed to previous FDA statements that “an ANDA holder wishing to add a warning to approved labeling should furnish adequate supporting information to FDA, which would then determine whether the labeling for all products should be modified.” The SG cited to federal regulations requiring generic drug companies “to provide FDA with information about labeling concerns” (citing 21 CFR 314.70); that they must inform FDA of side effects (adverse events), and report information that might affect the safety or labeling of their drugs. Citing to the FDA’s preamble to the ANDA application process, the SG made clear the obligations of a generic drug company which do not conflict with the traditional rule that their drug labeling mimic the brand name drug: “If an ANDA applicant believes new safety information should be added to a product’s labeling , it should contact FDA, and FDA will determine whether the labeling for generic and listed drugs should be revised. After approval of an ANDA, if an ANDA holder believes that new safety information should be added, it should provide adequate supporting information to FDA, and FDA will determine whether the labeling for the generic and listed drugs should be revised.” “Dear Doctor Letters” have often been debated as being an extension of a drug’s labeling and so generic drug companies have argued against submitting such informational letters to the medical profession. Plaintiffs in failure-to-warn suits contend that generic drug companies should send such letters to the medical profession (doctors and pharmacists) so as to educate them on new safety information that can reach their patients. The SG stated succinctly that there is “nothing [in the federal] regulations that forbids [a generic drug company] from unilaterally sending such correspondence.” At the very least, it appears from the SG briefing that a generic drug company, much like a labeling revision proposal, can propose a “Dear Doctor Letter” to the FDA. The United States Supreme Court will likely consider and resolve the issue by Summer 2011.