On August 13, 2021, FDA announced it would accept comments on a proposal to treat pre-Hatch-Waxman abbreviated new drug applications, or PANDAs, as NDAs. Despite objections, the agency is apparently already implementing changes.
With the 1984 Hatch-Waxman Amendments, generic drugs are approved as ANDAs under § 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA). Prior to the 1984 Amendments, FDA approved generics under § 505(b) submissions using reference drug safety and efficacy data.
Pre-Hatch-Waxman abbreviated new drug applications were essentially NDAs. But even after the Hatch-Waxman Amendments, the agency has always listed generic drugs (whether submitted under § 505(b) or 505(j)) as ANDAs in the Orange Book.
Things became less clear in 2017, when the new edition of the Orange Book expanded on the difference between reference listed drugs and reference standards. In an effort to clear up any confusion, FDA published a Federal Register announcement suggesting that pre-Hatch-Waxman drugs submitted under 505(b) be treated as NDAs and designated as RLDs, not as ANDAs and designated as Reference Standards. The agency’s announcement sparked some heated objection.
Importantly, Congress already considered the issue when it first arose in 1984, and concluded that FDA should treat pre- and post-Hatch-Waxman ANDA products the same--as 505(j) applications. Congress reaffirmed this decision by granting PANDAs prescription drug user fee exemptions.
Many PANDA products produce under $100,000 in annual gross sales. Accordingly, the fee exemptions offered by the Hatch-Waxman Amendments make a significant difference for many generic drugs approved prior to 1984. Annual prescription drug user fees can range in the hundreds of thousands of dollars. Yet, recent User Fee amendments have removed the PANDA fee exemptions, suggesting FDA may be moving forward with the proposal to treat PANDAs as full NDAs. FDA is also already assigning RLD designations to PANDAs in the Orange Book.
If FDA enacts the change, PANDA sponsors would face the same requirements and liabilities as NDA holders. Exemptions from post-marketing reporting requirements and other benefits that were created with the Hatch-Waxman Amendments would no longer apply.
For example, certain state tort laws place a duty directly on drug manufacturers to adequately and safely label all products. However, under post-1984 federal law, brand-name manufacturers are required to provide accurate and adequate labels while generic manufacturers are only required to match their labels to those of the corresponding brand-name drug.
In 2011, the Supreme Court held that federal law preempts the state law labeling requirements since federal law mandates different requirements on brand-name and generic-drug manufacturers. “It is beyond dispute that the federal statutes and regulations that apply to brand-name drug manufacturers are meaningfully different than those that apply to generic drug manufacturers. Indeed, it is the special, and different, regulation of generic drugs that allowed the generic drug market to expand, bringing more drugs more quickly and cheaply to the public.” Pliva v. Mensing, 131 S. Ct. 2567 (2011).
A change from treating PANDAs as ANDAs to NDAs could remove the protections offered by the Pliva v. Mensing decision and subject PANDA holders to state tort liability.
FDA stated that the change in administrative policy would offer “clarity both to prospective 505(j) ANDA applicants seeking to make generic versions of these products, and to applicants of 505(b)(2) applications that there is a finding of safety and effectiveness for these products that may be relied upon for approval.” The agency added that the change would continue to “advance competition and increase patient access to more affordable medicines.”