Academy of Managed Care Pharmacy Supports Legislation Banning Generic Exclusion Agreements

ALEXANDRIA, Va.--(BUSINESS WIRE)-- The Academy of Managed Care Pharmacy (AMCP) supports the inclusion of legislative language similar to S. 369 — the Preserve Access to Affordable Generics Act — in appropriations legislation now under consideration by the Senate. S. 369 would prohibit financial agreements between brand-name and generic pharmaceutical manufacturers to delay the marketing of lower-cost generic drugs.

“AMCP believes that such agreements deny patients access to affordable generic drugs, which unnecessarily raises prescription drug costs for patients, health plans and taxpayers,” said AMCP Executive Director Judith Cahill.

S. 369 currently is included in the Senate financial services appropriations bill. However, the fate of the generics provision and the appropriations bill is unclear. Congress, which returned Sept. 13, could pass continuing resolutions to fund the government or an omnibus appropriations bill, which may not include the ban on agreements to delay generic entry.

The need for congressional action on the issue was underscored by a Sept. 7, 2010, federal appeals court decision to decline to hear a case involving whether generic exclusion agreements in patent litigation are illegal. That decision was made even though 34 state attorneys general, the Federal Trade Commission, consumer groups, pharmacies and numerous academics sought a ruling by the court. The decision also sets up a conflict among the circuits that may ultimately be addressed by the U.S. Supreme Court.

The case involves an agreement between brand-manufacturer Bayer AG and generic manufacturer Barr Pharmaceuticals to delay marketing of a generic version of Bayer’s antibiotic Cipro.

“While AMCP realizes that appropriate incentives must be retained in order for brand-name manufacturers to recoup their investment in research and development of brand-name drugs, the use of strategies that can unnecessarily delay the entry of generic drugs into the marketplace must be prohibited,” Cahill said.

If there was concern regarding either the safety or efficacy of a generic drug, a delay would be warranted, she said. “However, it appears that most frequently, brand and generic manufacturers come to legal agreements that delay the entry of generic competitors for reasons other than safety and efficacy,” Cahill noted.

Generic drugs are approved by the FDA to be bioequivalent to their brand-name counterpart and are usually available at a significant cost-savings compared to the brand-name drug.

“At a time when health care expenditures are escalating at alarming rates, greater access to safe and effective generic drugs can aid in reducing prescription drug expenditures for patients and payers,” Cahill said. “AMCP supports legislative and regulatory changes that would promote the development and use of safe, efficacious and equivalent generic drugs and eliminate barriers to the entry of generic drugs into the marketplace.”

About AMCP

The Academy of Managed Care Pharmacy (AMCP) is a national professional association of pharmacists and other health care practitioners who serve society by the application of sound medication management principles and strategies to improve health care for all. The Academy's more than 6,000 members develop and provide a diversified range of clinical, educational and business management services and strategies on behalf of the more than 200 million Americans covered by a managed care pharmacy benefit. More news and information about AMCP can be obtained on its website, at The Academy observed its 20th anniversary in 2009.


Academy of Managed Care Pharmacy (AMCP)
Neal Learner, 703-683-8416 ext 608
[email protected]

KEYWORDS:   United States  North America  District of Columbia  Virginia

INDUSTRY KEYWORDS:   Health  Public Policy/Government  Congressional News/Views  Pharmaceutical  Public Policy