While reading a commentary today in Investor’s Business Daily (here) written by Peter Pitts, a former FDA Associate Commissioner, I became confused. The article’s focus was on two pieces of legislation (Creating and Restoring Equal Access to Equivalent Samples [CREATES] Act and the House’s Fair Access for Safe and Timely [FAST] Generics Act) and Mr. Pitts’ assertion that they “would undermine patient protections embedded in our drug approval system”.
These two legislative initiatives are focused on permitting generic drug companies to obtain samples of drug products to perform bioequivalence testing necessary to gain approvals for less expensive high quality generic products (which is, of course, the purpose of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act).
Bioequivalence studies are required to demonstrate that the proposed generic product has the same rate and extent of absorption as that of the innovator drug it seeks to copy, and, if found equivalent, would be expected to have the same effect as the innovator product. These tests typically require one dose of the innovator product and, at a later time, one dose of the generic product or vice versa. Blood levels of the drug are obtained over a certain period of time and those results are evaluated to determine if the two products are indeed bioequivalent.
Typically, generic companies purchase the brand name product on the open market to use in the bioequivalence testing. However, for some products, the FDA has determined additional safeguards need to be in place because the drug could pose significant risks to patients. Such products are typically placed under a risk evaluation and mitigation strategy (REMS), a program designed to protect patients by reducing the risks associated with the drug. These REMS programs often involve placing a patient in a registry, additional testing for potential pregnancy if the product is a teratogen, and perhaps special training requirements of physicians and/or patients or special patient monitoring programs. These REMS are designed for long term use of these products by patients in the marketplace and typically restrict access to the drug from sale to anyone other than the patient. Therefore, if a potential generic applicant cannot obtain samples, no bioequivalence testing can occur and no generics for the product can be approved.
The commentary seems to imply that, somehow, the entire safety aspects of the FDA review and approval process are thrown to the wind if a product covered by a REMS might be used simply for bioequivalence testing. Not so. For any of the products covered under a REMS, the FDA must assure that the protocol for bioequivalence testing incorporates equivalent patient protections as the approved FDA REMS program. While there is some discussion in the commentary of liability concerns, these do not in any way relate to the issue of a patient’s safety that are within the purview of the FDA and the firms that must conduct the bioequivalence testing under strict protocols that incorporate the essence of the REMS.
I am not convinced that the “apples and oranges” argument that the commentary makes (potential liability for the brand name company and the veiled link to lack of safety that bioequivalence testing would cause) is anything more than a smokescreen or scare tactic to keep generic sponsors from obtaining the samples they need to conduct the requisite testing to bring a generic version of one of the REMS/restricted distribution products to the market. I personally think it would be more of a liability and public health issue if a patient could not afford their medication for a potential life-threatening condition, because no generic was available.
