We often report about policies affecting access to safe and affordable medication through personal drug importation, and advocate for laws that help American patients – not corporate profits. Like safe personal drug importation, faster access to generic drugs right here at home would make prescription drugs more affordable for uninsured and under-insured Americans. Unfortunately, last month the 2nd U.S. Circuit Court of Appeals made a decision that adversely affects consumers but benefits pharmaceutical manufactures of both brand and generic drugs. The court decided to decline a review of the “pay-to-delay” ruling of Arkansas Carpenters Health and Welfare Fund v. Bayer AG means that, once again, pharmaceutical profits are protected at the expense of greater consumer access to affordable medication.
The decision declares that Bayer, the manufacturer of Cipro, an anti-infection drug, is lawful in paying Barr Laboratories, a large generic drug manufacturing company, $400 million to not challenge Bayer’s patent, which protects the high price now charged for Cipro. When generic drug manufacturers successfully challenge the validity of a patent, they are able to more quickly manufacture and sell low-cost versions of the drugs. Settlements that prevent such patent challenges cost consumers $3.5 billion a year, according to Federal Trade Commissioner Jon Leibowitz.
The 2nd Court’s decision was based on that same court’s earlier ruling of In re Tamoxifen Citrate Antitrust Litigation, 466, F. 3d 187 (2006), which found pay-offs to generic drug companies do not violate anti-trust law. There have been 53 similar pharmaceutical patent settlements, resulting in a variety of drugs with prices out of reach for many American patients.
Such rulings indicate that American patients can only win if the issue is decided differently by the Supreme Court or, and more likely, Congress changes the law.
Senator Herb Kohl is one congressman looking to make this happen. Senator Kohl introduced the Preserve Access to Affordable Generic Drugs Act (S. 369), legislation, which is still pending, to combat the practice of pay-off agreements between pharmaceutical companies and reduce the number of pay-for-delay settlements that keep generic drugs off the market. This legislation would be a big step in protecting consumer’s interests and health costs, and we hope for its success.