Posts Tagged: "drug pricing"

One day before comments closed on the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, published by the National Institute of Standards & Technology (NIST) and the Department of Commerce last month, the Department of Health and Human Services (HHS) denied an appeal of a decision not to march in on the blockbuster prostate cancer drug, Xtandi®.

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.

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.

The National Institute of Standards & Technology (NIST) and the Department of Commerce today published a draft version of a Federal Register Notice seeking comments on a proposed framework for deciding whether and when to exercise march-in rights under the Bayh-Dole Act that would significantly broaden the criteria for compulsory licensing of patented technology developed with federal funding. While Bayh-Dole contemplates march-in rights, the law strictly limits the situations in which they can be exercised and does not make any reference to pricing as a criterion for marching in. But under the proposed framework, an agency may consider “[a]t what price and on what terms has the product utilizing the subject invention been sold or offered for sale in the U.S.” and whether “the contractor or licensee [has] made the product available only to a narrow set of consumers or customers because of high pricing or other extenuating factors”.

IPWatchdog’s Life Sciences Masters 2023 concluded today, following three days of panels that tackled some of the most pressing issues facing intellectual property professionals in the life sciences space. In the spotlight was the Biden Administration’s recent passage of the Inflation Reduction Act (IRA) and its potential impact on future drug development in the United States. Prescription drug pricing controls are one aspect of the IRA, a landmark piece of legislation passed by Congress last August that also directs funding to be spent on clean energy projects and increased tax enforcement. The IRA authorizes the Health and Human Services (HHS) Secretary to establish a Drug Price Negotiation Program, codified at 42 U.S.C. § 1320f, to establish maximum fair prices of certain drugs that become eligible for the program because they constitute a large portion of expenditures by Medicare Part B and Part D patients. Pharmaceutical companies who do not agree to the price set during negotiations with HHS will have to pay a new excise tax codified at 26 U.S.C. § 5000D calculated based on daily sales and starting at 65%.

Last week, the White House announced that the manufacturers of all ten of the drugs singled out by the Centers for Medicare and Medicaid Services (CMS) and its drug price negotiation program (DPNP) have “agreed” to participate therein. The announcement concerns the manufacturers reluctantly agreeing to subject themselves to the sweeping drug price “negotiation” provisions of the Inflation Reduction Act (IRA), which was passed last year. Those provisions empower CMS to essentially dictate whatever price it pleases for a set of prescription drugs, the first ten of which were announced at the end of August.

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.

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.

On July 31, the National Institutes of Health (NIH) hosted a virtual workshop titled Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer. Public comments submitted to the NIH ahead of the event reflect current tensions between advocates supporting either private commercialization or government pricing control of federally-funded medical breakthroughs commercialized by private companies.

Rattled by the failure of the Biden Administration to bow to pressure to misuse the march-in rights provision of the Bayh-Dole Act so the government can regulate prices on products based on federally funded inventions, Senator Bernie Sanders (I-VT) and his allies are doubling down. And the impact of National Institutes of Health (NIH)-supported research is now in jeopardy. Sanders taunted the Administration, pledging to hold up the nomination of Dr. Monica Bertagnolli to head the NIH until President Biden submits to his demands to do more to control drug prices, including requiring that any therapy-based on an invention arising from NIH funding must be sold at a “reasonable price.”

On June 9, the U.S. Chamber of Commerce and several affiliate organizations filed a lawsuit in the Southern District of Ohio raising a series of constitutional challenges to provisions of the Inflation Reduction Act (IRA). At issue in the lawsuit are several statutes granting the U.S. Department of Health & Human Services (HHS) the authority to set prices for Medicare drugs. The U.S. Chamber is challenging a lack of oversight for so-called “negotiation” procedures as well as an onerous excise tax on several grounds, including separation of powers and due process violations.

A bipartisan group of congress members sent a letter to U.S. Patent and Trademark Office Director Kathi Vidal late last week urging her to implement some of the proposals outlined in her October 2022 Request for Comments on Robust and Reliable Patents in order to address problems around drug pricing. The letter was sent by Representatives Jodey Arrington (R-TX), Lloyd Doggett (D-TX), Michael Burgess (R-TX), Ann McLane Kuster (D-NH), and Darrell Issa (R-CA). They specifically expressed concerns about the practice of “patent thicketing” and gave the example of two separate patents granted for a rheumatoid arthritis biological drug by the same company, where the difference in the claims was seemingly minor. The letter cites to a video titled “The Case for Patent Reform,” featuring Senior Vice President and Head of Legal & Intellectual Property Biosimilars at Fresenius Kabi, for this reference.

Today, the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) published a Patient Access Report profiling the many ways in which drug pricing controls, often enacted in the name of ensuring widespread access to low-cost medicines, actually result in less access to innovative medicines that are more widely available in free markets. The GIPC’s report comes at a time during which the Biden Administration has taken recent action on drug pricing provisions included in the Inflation Reduction Act passed into law last August, which could have deleterious effects on patient access in the United States.

On Thursday, the Senate Judiciary Committee passed a number of bills targeting the pharmaceutical industry. The bills passed on a bipartisan basis and with minimal discussion, by a voice vote, though Senator Mike Lee (R-UT) reiterated concerns he has had since the bills’ introduction. Here is a recap of what the bills aim to do.