Posts Tagged: "Xtandi"

HHS Denies Appeal of Xtandi March-In Petition as Comments Close on Proposed Framework

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®.

GIPC Letter to Senators Pushes Back on ‘False Narrative’ Exaggerating Public Role in Private Drug Development

On March 22, the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) sent a letter addressed to Senators Bernie Sanders (I-VT) and Bill Cassidy (R-LA), respectively the Chair and Ranking Member of the U.S. Senate Committee on Health, Education, Labor, and Pensions, regarding a Health Committee hearing held that same day on the pricing of Moderna’s COVID-19 vaccine. The GIPC’s letter sought to push back on false narratives regarding the role of public funding in private pharmaceutical research & development (R&D,) and also doubled down on the Center’s criticisms of drug pricing controls in the recently enacted Inflation Reduction Act.

It’s Time for NIH to Uphold the Law, Once Again

As discussed previously, the critics are in full howl now that their attempts to enact legislation controlling drug prices has failed once again. They are applying unprecedented political pressure on Secretary Xavier Becerra at the Department of Health and Human Services (HHS) to misuse the march in provisions of the Bayh-Dole Act to accomplish their goal. Nearly 100 distinguished organizations and individuals endorsed the following letter from the Bayh-Dole Coalition, which I lead, warning HHS not to take this disastrous misstep. Here’s what we said.

Bernie Sanders’ Really Bad Idea

Sen. Bernie Sanders (I-VT) introduced legislation requiring every agency and non-profit entity to include a “reasonable pricing” provision based on King’s formula for any life science invention made with government support. Apparently the colossal failure of a similar requirement forced on the National Institutes of Health (NIH) in the 1990’s which led to the collapse of industry partnerships without any reduction in drug prices is either unknown, or made no impression on Sen. Sanders. Or perhaps like his trust in socialism, he thinks that what failed in the past will somehow work by some weird magic if trotted out again.

Proposal from Senator King Won’t Reduce Drug Prices, Just Innovation

Many were stunned to learn that Senator Angus King (I-ME) included language undermining the Bayh-Dole Act in the report of the Senate Armed Services Committee as it approved the National Defense Authorization Act. The the language “directs” the Department of Defense (DOD) to issue compulsory licenses under Bayh-Dole “whenever the price of a drug, vaccine, or other medical technology is higher in the U.S. than the median price charged in the seven largest economies that have a per capita income at least half the per capita income of the U.S.” The provision gives the Department no discretion— it must comply. Apparently no one bothered to check with DOD or anyone familiar with the law to discover that this language incorporates a long discredited theory of how Bayh-Dole operates, or of the significant damage it would do to the development of badly needed medicines and the U.S. economy. The bill is headed to the full Senate for consideration. So before that happens, let’s consider why this is such a bad idea.