The Affordable Prescriptions for Patients Act of 2019 (S. 1416) aims to lower prescription drug costs by limiting anticompetitive behavior from large brand name drug manufacturers. The bill includes proposals to prevent manufacturers from using two well-known gaming tactics: (1) product hopping, through both hard and soft switches; and (2) biologic product patent thickets. The experts’ opinions below focus only on Sec. 2 of S.1416, which aims to prevent product hopping.
Product hopping can occur through either a hard switch or a soft switch by the manufacturer. A hard switch occurs when the brand manufacturer of the reference drug removes their product from the FDA’s approved drug list and introduces a new, follow-on medication right after being alerted of a generic ANDA application. A soft switch occurs when brand manufacturers impede the generic manufacturer, so that they are given more time to market and sell their next, follow-on drug. In both instances, the brand manufacturer will have patients switched over to the new, follow-on medication before generics for the reference product are released.
Sec. 2 of the Affordable Prescriptions for Patients Act of 2019 seeks to limit product hopping, through both hard and soft switches, by enabling the Federal Trade Commission (FTC) to prohibit such anticompetitive behavior. The FTC may deny large brand manufacturers attempt to remove drugs listed on the FDA’s approved drug list, when done between notification of generic product application and 180 days after the product has been on the market. Brand manufacturers may still fight the allegations in court, if they are able to prove that their actions were justified for the safety and best health outcomes for patients and not solely intended to restrict generic competition.
The expert panel agreed that this policy would reduce drug spending but were split on if it would be a minimal or moderate reduction. The majority of the experts felt drug list prices would not be affected by this policy, but unanimously agreed it would moderately decrease drug net prices. While most of the experts opined that there would be a moderate increase in drug access across all patient groups, Medicaid and rare disease patients’ access would not be affected.
The panel was spilt on if this policy advances drug spending policy, buy a slight majority felt it would moderately advance drug spending policy. Experts unanimously agreed that the precedent-setting value of the policy is a strength. Other strengths highlighted include the size of the affected patient population and the evidence to support the legislation. Experts were split if the ability for the policy to be effectively implemented would be a weakness of the policy or if it remains unknown.
Experts highlighted many considerations for policymakers. The most important considerations that were mentioned are the absence of additional resources for the FTC to enforce the policy, the aggressiveness of the FTC to effectively curb anticompetitive behavior, and that product hopping is a relatively minimally used gaming tactic, so manufacturers will be able to continue engaging in other anticompetitive behavior. Additional concerns that should be considered are that the policy could have unintended consequences that discourage genuine product improvements, the policy also does not clearly define clinical factors, and that if manufacturers are able to justify their conduct, it may weaken the effect of litigation. Finally, it is unclear to what extent the rulings will depend on a comparison of the safety, effectiveness, and tolerability of the follow-on drug relative to the original, reference listed drug.