Politics, Policy & Law

Medicare Part B premium spike could create pressure for international reference pricing

The Trump administration Monday attributed a jump in Medicare Part B premiums and deductibles to increasing spending on physician-administered drugs. The administration is likely to use the increases to justify its proposal for an international...

White House pushing Grassley-Wyden drug pricing bill, including inflation caps

Enacting drug pricing legislation by the end of December based on the Prescription Drug Pricing Reduction Act (PDPRA) is a top Trump administration priority, Joe Grogan, director of the White House Domestic Policy Council, said...

Gilead to seek pause in U.S. government HIV PrEP suit until patent office rules on patent validity

Gilead plans to ask a federal court to pause a patent infringement lawsuit the federal government filed against the company’s Truvada and Descovy HIV pre-exposure prophylaxis (PrEP) drugs pending resolution of Gilead’s patent challenges by...

FDA takes next step in new drug reorganization, including revamping oncology review

FDA announced the establishment of three new offices as part of a wide-ranging reorganization of the Center for Drug Evaluation and Review’s Office of New Drugs. The new organization is flatter and includes new disease-focused...

HELP chair endorses Hahn for FDA commissioner, sets Nov. 20 confirmation hearing

Sen. Lamar Alexander (R-Tenn.), chairman of the Senate Health, Education, Labor and Pensions Committee, expressed support Wednesday for Stephen Hahn to be confirmed as FDA commissioner. The HELP Committee will hold a hearing on Nov....

Giroir to split time between FDA, HHS pending Hahn confirmation

Brett Giroir will continue to serve as HHS's assistant secretary for health while heading FDA, according to sources at HHS. Giroir will split his time between FDA’s White Oak campus in Silver Spring, Md., and...

Trump administration shifts Sharpless to make way for Hahn

The Trump administration has launched a game of musical chairs that is intended to clear a path for Stephen Hahn to be confirmed as FDA commissioner. When the music stops, it is possible that Hahn...

Survey finds Europe top alternative for Chinese life science investors amid CFIUS concerns

A survey of Chinese investors revealed broad concern about U.S. restrictions on foreign investment in the life sciences that is diverting Chinese investments to other countries, with Europe cited as the top alternative for investment....

FDA’s Project Facilitate fielded 161 compassionate use requests in first three months

Project Facilitate, an FDA call center that guides physicians through the process of obtaining expanded access -- or compassionate use -- to investigational cancer therapies, handled about 161 requests from its launch on June 3...

CMS proposes coverage of next-generation sequencing for advanced cancer

CMS has proposed that next-generation sequencing should be covered for Medicare beneficiaries with advanced cancer. In a proposed decision memo , the agency said NGS as a diagnostic laboratory test when performed in a CLIA-certified...

Cuccinelli accepts responsibility for decision to deport patients

Ken Cuccinelli, acting director of U.S. Citizenship and Immigration Services, Wednesday took responsibility for the Trump administration’s August 2019 decision to initiate deportation proceedings against critically ill patients and their families. Cuccinelli testified to the...

FDA’s Woodcock highlights gaps in knowledge about Chinese APIs, promotes advanced manufacturing to bolster U.S. security

A congressional hearing Wednesday on safeguarding pharmaceutical supply chains will focus on concerns that reliance on Chinese APIs threatens U.S. national security and creates health risks for American patients. The House Energy and Commerce Committee’s...

Berkeley-Tsinghua transnational IP meeting highlights progress, risks for U.S. and China

Participants at a Berkeley conference Tuesday outlined both encouraging and concerning signals for transnational IP litigation in the U.S. and China. While available data suggest domestic and foreign parties have received equitable treatment in each...

NIH, Gates Foundation back sickle cell, HIV cures with $200M

Following calls from the White House to end the U.S. HIV epidemic, NIH and the Bill and Melinda Gates Foundation announced a collaboration to invest at least $200 million in the development of low-cost in...

AdvaMed’s Center for Digital Health will focus on barriers to tech implementation

The Advanced Medical Technology Association's new Center for Digital Health will initially advocate for issues relating to cybersecurity, artificial intelligence and information policy. The center, which launched last week, has 47 members who are also...