Fix Drug Approval Announcement ‘Non-system’: Attorneys
Three Hyman, Phelps & McNamara attorneys — Kurt Karst, John Fleder, and Robert Dormer — say that the current FDA “non-system” of announcing major drug approval decisions when the agency wants to do so, with no advance notice to potential litigants, courts, or the public regarding when the decision will be made, let alone what the decision will be, is broken and needs to be fixed. Writing in an online white paper, the attorneys say the issue often arises when the agency is making a difficult decision when a blockbuster drug is about to go off patent protection.
There may be a question of whether the branded drug company is entitled to extended exclusivity, or a branded company’s argument that a generic drug should not be approved because it does not meet ANDA requirements, or a generic company’s argument that it is entitled to 180-days of marketing exclusivity or that there is no exclusivity under the Federal Food, Drug, and Cosmetic Act.
“Companies that want FDA to take action in one of these situations often file citizen petitions seeking a particular result,” the paper says. “Although FDA has acknowledged that the agency is not legally required to couple its decision on the citizen petition with a decision to approve a generic drug, or grant (or not grant) 180-day exclusivity, FDA’s practice for many years has been to simultaneously announce both decisions.”
As a result of this non-process, the attorneys write, FDA has succeeded in irritating and frustrating federal judges, innovator drug companies, generic drug companies, the investment community, the public at large, and even the agency’s own attorneys at the Justice Department. The attorneys say the fact that their firm has represented companies that have sued FDA to challenge such a decision and also companies that defend the agency’s decision in a case filed by another company gives them a unique perspective on the issue, although they do not offer a specific solution.
The paper reviews two cases — Hi-Tech Pharmaceutical Co. v. FDA and AstraZeneca Pharmaceuticals v. Burwell — and says that no one wins in these situations. “As we see it,” the authors write, “FDA’s ‘system’ pleases no one and does not appear to be legally mandated. Moreover, whatever advantage FDA may think it is getting from hiding the ball from the world on the timing and substance of these decisions is more than overcome by the criticism the agency has received from judges…. FDA has badly hurt its own credibility with judges, the very people who decide these cases, by refusing to inform potential litigants who may find their cases bumped from the docket when FDA finally gets around to making a decision…. There appears to be ample authority conferred on FDA to make changes without the need for additional legislation to be enacted. If legislation is needed, we call on FDA to spearhead a legislative fix. Congressional oversight committees may be a sound vehicle to compel FDA to focus on this problem. Perhaps the Department of Health and Human Services may be able to force FDA to change its ways. FDA needs to involve interested stakeholders in this process. We also urge FDA to communicate with the courts … to try to get judicial input.”