FDA Generic Drug Labeling Rule ‘Dead,’ Attorney Says
Attorney James Beck (Reed Smith) says that FDA’s extension of the comment period for its proposed generic drug labeling rule until 4/2017, after the upcoming presidential election, means that “for all practical purposes … the proposed rule is dead.” In an online blog post, Beck says that the law that requires generic drug labeling to be the same as the branded drug labeling cannot support the agency’s proposal to allow changes-being effected labeling changes.
He says he believes that the proposal always has been pushed by the “political FDA leadership” to take steps to overturn two 5-4 Supreme Court generic drug preemption decisions. “They are doing this as affirmative political payback to satisfy the plaintiffs’ trial bar … [which has] been major political supporters of the current administration, and as long as they tell FDA’s political leadership to jump, during this administration the response will be ‘how high.’”
According to Beck’s analysis, the non-political part of the agency, which is by far the largest part, has institutional needs, including avoiding another in a recent string of losing court battles. He notes that the generic drug industry has vowed an administrative challenge to any agency rule that violates the statutorily-mandated sameness of generic and branded labels. “Given the express language of the Waxman-Hatch amendments,” he writes, “that challenge is almost certainly a stone, cold loser. Now, nobody has to (endure such a battle). No matter what the result of the election, the underlying political calculus that has so far driven FDA’s proposed generic labeling rule has ceased to exist.”
Beck notes that in the two Supreme Court preemption cases, Mensing and Bartlett, all five Republican nominees to the court formed the majority and all four Democratic nominees dissented. “The Supreme Court lineup … indicates that judicial and political partisanship are strongly aligned with respect to generic drug preemption,” he writes.
He concludes that if Democrats are able to appoint a Supreme Court nominee to replace Justice Antonin Scalia, the plaintiff bar should have an easier time having the two decisions overturned than it would face trying to pursue an FDA rule that likely would not withstand legal challenges. By the same token, if Republicans win the election, “FDA’s political leadership will be promptly replaced, and the proposed generic labeling rule will be withdrawn, and perhaps be replaced with the alternative expedited agency review proposal that would actually expand preemption. Either way, there will be no need for FDA to continue with the current controversial generic labeling proposal that carries significant litigation and other (congressional attempts to cut off funding for implementation) risks to the agency’s institutional values, which its permanent legal staff would no doubt be happy to avoid.”