FTC Staff Report Finds 60 Percent Increase in Pharmaceutical Industry Deals That Delay Consumers' Access to Lower-Cost Generic Drugs

Pharmaceutical companies struck an unprecedented number of deals in Fiscal Year (FY) 2010 in which the manufacturers of branded products paid potential generic rivals and generic companies agreed to defer the introduction of lower-cost medicines for American consumers, according to an overview of industry data released by the staff of the Federal Trade Commission.

The FTC staff report found that the number of these deals skyrocketed more than 60 percent, from 19 in FY 2009 to 31 in FY 2010. Overall, the agreements reached in the latest fiscal year involved 22 different brand-name pharmaceutical products with combined annual U.S. sales of about $9.3 billion.

“Collusive deals to keep generics off the market are already costing consumers and taxpayers $3.5 billion a year in higher drug prices,” said FTC Chairman Jon Leibowitz. “The increasing number of these deals is a win-win proposition for the pharmaceutical industry, but a lose-lose for everyone else.”

Millions of Americans rely on generic drugs to make medicine affordable, and generics also help hold down costs for taxpayer-funded health programs such as Medicare and Medicaid. Generic prices are typically at least 20 to 30 percent less than the name-brand drugs, and in some cases are up to 90 percent cheaper.

In recent years, certain brand-name companies have paid generic challengers to settle their patent challenges and delay the introduction of lower-cost medicines. An FTC staff study has found that such settlements that include a payment delay generic entry by 17 months longer on average than those that do not include a payment.

The FTC has challenged a number of these patent settlement agreements in court, contending that they are anticompetitive and violate U.S. antitrust laws. The agency also has supported legislation in Congress that would prohibit settlements that increase the cost of prescription drugs.

The staff report summarizes data on patent settlements filed with the FTC and the Department of Justice during FY 2010. There were a total of 113 final patent settlements. Of those, 31 settlements contained a payment to a generic manufacturer and also restricted the generic’s ability to market its product. Of those 31 settlements, 26 involved generics that were so-called “first filers,” meaning that they were the first to seek FDA approval to market a generic version of the branded drug. Because of the regulatory framework, when first filers delay entering the market, other generic manufacturers can also be blocked from entering the market, which makes such patent settlement deals particularly harmful to consumers.

The staff report issued today also cited three other settlements in FY 2010 that did not record any explicit compensation for the generic, but provided other assurances that may have had the effect of compensating the generic for delaying entry.

The FTC’s Bureau of Competition works with the Bureau of Economics to investigate alleged anticompetitive business practices and, when appropriate, recommends that the Commission take law enforcement action. To inform the Bureau about particular business practices, call 202-326-3300, send an e-mail to antitrust@ftc.gov or write to the Office of Policy and Coordination, Room 394, Bureau of Competition, Federal Trade Commission, 600 Pennsylvania Ave, N.W., Washington, DC 20580. To learn more about the Bureau of Competition, read “Competition Counts” at http://www.ftc.gov/competitioncounts.