Reporter Resources: Branded and Generic Drug Competition
U.S. consumers save millions of dollars each year by buying generic alternatives to branded prescription drugs, and the FTC is committed to ensuring they have access to generic alternatives when possible.
This is not only an issue of competition, but of consumer choice. By using the drug approval and Hatch-Waxman processes to keep generic alternatives off the market or delay their entry, companies not only hurt competition, but deny consumers the right to choose a cheaper alternative form of medication.
While the Commission lost the Schering Plough case when the Supreme Court declined to hear the agency’s appeal (denial of cert), the FTC remains dedicated to ensuring that generic and branded drug competition remains vigorous, while understanding the fact that drug companies have the right to protect legal patents. Under the Medicare Modernization Act (MMA) drug companies are now required to report certain litigation settlements to the FTC, which issues a report on these settlements each year. Recent reports illustrate that the number of brand payments to generic firms to settle pending patent litigation has increased significantly since the Schering ruling. Those reports can be found at: http://www.ftc.gov/bc/healthcare/drug/index.htm. The Commission will bring cases in the future, if appropriate.
The FTC supports legislation designed to address the exclusion-payment problem. In general, these bills are designed to stop drug companies from mis-using the Act to their competitive advantage by paying competing firms to create a bottleneck in the generic pipeline by failing to bring their products to market. Recent testimony presented to the House Energy and Commerce Committee explains the Commission’s views on this subject.
In addition to patent-settlement issues, the FTC is working to promote competition and protect consumers of pharmaceuticals in cases such as Warner-Chilcott/Barr, which did not involve a patent and pharmaceutical merger challenges, where the agency also has been active recently.
Useful Links
Information related to healthcare industry competition and the FTC’s role in enforcing competition in the generic and branded drug marketplace can be found at: www.ftc.gov/bc/healthcare. All FTC press releases related to competition in the health care industry from 1995 to the present can be found at: http://www.ftc.gov/bc/healthcare/news/index.htm.
More information about competition and anticompetitive practices that can be applied to the healthcare industry can be found at: http://www.ftc.gov/bc/healthcare/index.htm.
An overview of healthcare and pharmaceutical antitrust actions can be found at:
http://www.ftc.gov/bc/healthcare/antitrust/index.htm.
Cases, proceedings, and other formal actions taken by the Commission in the healthcare industry can be found at: http://www.ftc.gov/bc/healthcare/antitrust/cases.htm.
Finally, recent testimony on the current state of the U.S. pharmaceutical industry with respect to generic and branded competition and entry – as well as proposed legislation in this area – can be found at: http://www.ftc.gov/os/testimony/P859910 Protecting_Consume_ Access_testimony.pdf
