Examining the Competitive Impacts of State Regulations and Naming Conventions Concerning Follow-on Biologics
- Created on Monday, 30 December 2013 16:01
- Written by IVN
Washington, DC - The Federal Trade Commission announced its one-day public workshop on competition and follow-on biologics has been rescheduled for Feb. 4, 2014. The workshop will be held at the FTC’s Conference Center located at 601 New Jersey Ave., NW, in Washington, and will examine competition issues surrounding biologic and follow-on biologic medications.
The event, originally scheduled for Dec. 10, 2013, was postponed due to a weather-related closure of the federal government.
As explained in the Commission’s Federal Register notice, the workshop will specifically focus on how state regulations and naming conventions may impact the development of, and competition for, follow-on biologics.
This workshop reflects the FTC’s longstanding interest in promoting competition in the pharmaceutical industry. Competition between “small molecule” branded drugs and lower-priced generic alternatives, facilitated by state automatic substitution laws, has substantially reduced prescription drug prices and expenditures. In 2010, to encourage price competition and innovation in markets for biologics, Congress passed the Biologics Price Competition and Innovation Act (BPCIA), which established an abbreviated regulatory pathway for the approval of follow-on biologics by the U.S. Food and Drug Administration (FDA).
Biologics, which comprise the fastest-growing sector of pharmaceuticals, target such difficult-to-treat diseases as cancer, diabetes, and multiple sclerosis. They include vaccines, antitoxins, blood products, proteins, and monoclonal antibodies. Biologic medicines consist of molecules that typically are larger and more structurally complex than those of traditional small molecule drugs. Biologic medicines are very expensive; one year of treatment can range from $50,000 to $250,000, and access to biologics is often restricted because of cost.
Although to date, the FDA has not approved any follow-on biologic that might compete against a “reference” biologic, some state legislatures have recently considered and passed laws that could affect the substitution of follow-on biologics for reference biologics. Some commenters have raised concerns that state-level regulatory barriers may raise costs and lessen incentives to develop lower cost follow-on biologics, thus deterring the development of competition between reference and follow-on biologics.
The FTC’s workshop will examine how biologic competition could be affected by state regulation, and also by the naming conventions currently under discussion for follow-on biologics. It also will examine ways to structure the regulations and naming conventions so as to facilitate innovation and competition, while protecting patient health and safety. The workshop will explore if and when potential entrants would be willing to invest in developing follow-on biologics using the abbreviated regulatory pathway created by the (BPCIA), as well as the experience of other countries with regulatory systems that enable follow-on biologic competition.
Questions the FTC will pose include:
- How would the new state follow-on biologic substitution laws passed this year, or similar proposals pending in other states, affect the competition expected between or among biosimilar, interchangeable, and reference biologic medicines?
- What rationales are being offered to support new state proposals and laws for regulating follow-on biologic substitution?
- What are the compliance costs associated with the new state requirements, and how are they likely to affect follow-on biologic competition?
- Would it benefit competition if the FDA published an authoritative listing of follow-on biologics that are biosimilar to, or interchangeable with, reference biologics? Would such a publication facilitate substitution?
- What has been learned from the experience with competition between branded and generic drugs under the Hatch-Waxman Act about the incentives necessary to encourage physicians and patients to switch between branded and lower cost, therapeutically substitutable products? Do naming and name changes affect switching? If so, how?
- How does the use of certain identifiers, such as National Drug Codes, brand names, or nonproprietary names, work with existing adverse event reporting, track and trace, or other pharmacovigilance systems?
The workshop is free and open to the public, and will also be webcast. In the near future, the Commission will publish an updated agenda and list of speakers. The FTC is accepting public comments through March 1, 2014. This deadline is unaffected by the rescheduling of the event.
The Commission vote approving the notice announcing the workshop was 4-0. The notice will be published in the Federal Register shortly.
Copies of the document mentioned in this release are available from the FTC’s website at http://www.ftc.gov and from the FTC’s Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, DC 20580. Call toll-free: 1-877-FTC-HELP.