Groups Suggest Ways to Improve Waxman-Hatch
Responding to an FDA request for comment on ensuring a balance between innovation and access in the Waxman-Hatch Act, the Biotechnology Innovation Organization (BIO) says there is an appropriate and necessary role for state laws in outlining the circumstances, authorities, and communication protocols for product substitution. “The designation of a generic product as therapeutically equivalent is a scientific determination that does not obviate the need for professional decision-making at both the physician and pharmacist level,” it says.
BIO notes that the federal legislative language on interchangeability does not expressly preempt state law, and says that nothing in the legislative history suggests that Congress intended interchangeability determinations to preempt state law. “Indeed,” it declares, “the available evidence suggests the opposite.”
Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports the important role of generic products and describes ways in which Waxman-Hatch has fostered competition through the timely entry of generic drugs. On the other hand, it says, FDA must also consider the Waxman-Hatch amendments from the perspective of incentives for innovation. The trade association says it believes there are areas where incentives for innovation may be insufficient.
“With respect to data protection, Waxman-Hatch’s incentives for innovation have not proven to be as robust as intended,” PhRMA says. “Similarly, the incentives provided by three-year exclusivity have been significantly weakened and do not sufficiently support the types of innovations eligible for such exclusivity (for examples, new uses of approved products)…. When patents are considered, there are also areas where incentives for innovation have weakened over time.”
The comment letter also addresses specific issues relating to citizen petitions, risk evaluation and mitigation strategies, post-approval reformulations and other changes, and product appearance.
Finally, the Association for Accessible Medicines, representing manufacturers and distributors of finished generic pharmaceutical products, says that although Waxman-Hatch “has been a resounding success in creating a vibrant generic drug marketplace, it is concerned that some innovator pharmaceutical companies find innovative ways to ‘game’ the system and slow the availability of affordable generic and biosimilar medicines to patients.” The group says it is “pleased that FDA is now considering regulatory actions to deter the anti-competitive practices adopted by some brand companies and to reestablish the Waxman-Hatch balance.” It also calls on the agency to maintain a focus on the impact of anti-competitive tactics in the area of biologics.