Posts Tagged: "price controls"

Biden Admin and U.S. Chamber Clash Over IRA Drug Pricing Impact

Today, the U.S. Department of Health and Human Services (HHS) made its initial offers to pharmaceutical companies pursuant to the Biden Administration’s Inflation Reduction Act of 2022 (IRA), which allows the U.S. Government to “negotiate” Medicare drug prices under a set framework based upon the amount of time a drug has spent on the market. Opponents of the program, including the U.S. Chamber of Commerce, which is suing the government over the plan, argue it cannot be characterized as a voluntary negotiation since the affected companies would be subject to onerous excise taxes for refusing to participate and because it would have devastating consequences for patients if companies were to actually pull the affected drugs. The amounts of today’s initial offers were not revealed.

The March-In Drug Price Control Narrative Crumbles While Its Damage to American Innovation Grows

It was little more than a month ago when the Biden Administration unleashed its draft guidelines for applying the march-in provisions of the Bayh-Dole Act. For more than 43 years, the law was implemented as written. Every Administration—including the Biden Administration—rejected repeated attempts to misuse the law so the government could license copiers when critics felt that a product based on a federally-funded invention was too expensive. This was mainly sought under the guise of lowering drug prices. Even though the Administration issued a stinging denial of the most recent attempt last March, in December it reversed course.

Report: U.S. Leadership in Biopharma R&D to Plummet Post-Price Controls

The U.S. Chamber of Commerce released a report today predicting that proposals by the Biden Administration to impose price controls on certain pharmaceuticals will reduce the number of clinical trials “by thousands across all categories of research examined and by up to 75% in some therapeutic areas,” eventually turning the United States into a “research desert.” The report comes on the heels of a Federal Register Notice last week that proposed a framework for expanding the use of march-in rights under the Bayh-Dole Act to circumstances in which qualifying drugs are priced too high.

IP VIPS Send Letter to Congress Countering Calls for Government Price Controls on Drugs

Twenty-five intellectual property luminaries sent a letter today to several members of Congress asking them to beware of misleading and inaccurate assertions by “activists and academics” that government price controls on drugs will lead to lower costs for consumers. The letter was sent to Senators Bernie Sanders (I-VT) and Bill Cassidy (R-LA), Chairman and Ranking Member, respectively, of the Senate Committee on Health, Education, Labor & Pensions; and Representatives Jason Smith (R-MO) and Richard Neal (D-MA), Chairman and Ranking Member, respectively, of the House Committee on Ways and Means.

U.S. Chamber Says Biden Administration is Rushing IRA Drug Pricing Regime Under Cloud of Legal Uncertainty

On August 28, officials from the U.S. Chamber of Commerce held a video call to discuss the trade organization’s legal action against the U.S. Department of Health & Human Services (HHS), including a motion for preliminary injunction filed against the HHS last week in U.S. district court. The U.S. Chamber officials noted that the legal uncertainty looming over the HHS’ implementation of drug price control mechanisms under the Inflation Reduction Act (IRA) will cast a significant pall over the Biden Administration’s celebration of the program one year on.