Politics, Policy & Law

HHS report finds Part D rebates not keeping up with rising drug prices

An HHS Office of the Inspector General report shows Medicare Part D rebates are not keeping up with rising prices for brand drugs. The report examined 1,510 brand name Part D drugs that received rebates...

FDA’s international cancer drug review initiative launches with first approval

FDA believes its new framework for the submission and review of cancer drugs concurrently in multiple countries will speed up patient access to new therapies and streamline drug development. The agency unveiled the framework, dubbed...

Another chance to renew the social contract

The Business Roundtable, a club of CEOs of many of the largest U.S. corporations, has given biopharma companies a new impetus for telling the public how they plan to live up to their social commitments....

Proposal could clear obstacle to outcomes-based contracts

The Duke-Margolis Center for Health Policy has released a proposal that could remove the biggest barrier to the widespread adoption in the U.S. of value-based payment contracts for medicines. A technical fix to the Medicaid...

Few answers from hearing on medical deferred action

Testifying Wednesday at a congressional hearing, Trump administration officials were unable to explain why hundreds of people with life-threatening conditions have been threatened with deportation. The House Committee on Oversight and Reform’s subcommittee on civil...

Leaked Pelosi plan uses international reference index to set U.S. drug prices

A leaked draft of a drug pricing plan under development by House Speaker Nancy Pelosi seeks to give the HHS secretary the ability to negotiate U.S. drug prices based on an international price index. Pelosi’s...

BIO expects year-end drug pricing legislation

Congress is likely to enact drug pricing provisions as part of a year-end budget bill rather than as stand-alone legislation, BIO President and CEO Jim Greenwood said Monday. While there is unanimity on Capitol Hill...

China moves to take centralized procurement nationwide

China's Joint Procurement Office will expand its pilot program for centralized procurement of generic and off-patent originator drugs nationwide, a move that could further cut prices of the 25 drugs in the program. Under the...

FDA commissioner search narrowed to three

HHS Secretary Alex Azar has submitted three names to the White House as potential FDA commissioners, individuals who are familiar with the process of selecting and vetting candidates told BioCentury. In addition to Acting Commissioner...

U.S. reconsidering deportation orders for patients receiving medical treatment

Following a media firestorm and outcry from patient groups and biopharma executives, the Trump administration has said it will reconsider a policy change that could lead to the deportations of a rare disease patient and...

Former commissioners, patient groups endorse Sharpless as permanent FDA leader

Five former FDA commissioners and dozens of patient groups have publicly asked President Donald Trump and HHS Secretary Alex Azar to nominate acting FDA Commissioner Ned Sharpless as permanent commissioner. The endorsements come as the...

Biotech leaders outraged by planned deportation of rare disease patient

Biotech industry leaders have expressed outrage at reports that a patient who is receiving a life-saving therapy in the U.S. that is unavailable in her country is facing the threat of deportation. Media reports indicate...

Where innovators see room for improvement in China's Drug Administration Law

The innovative drug industry sees room for improvement and clarification in China's Drug Administration Law, which excluded IP reforms such as patent linkage and data exclusivity. China's National People's Congress (NPC) passed the revised Drug...

Industry group responds to Dutch Minister’s 'something’s gotta give' reaction to drug price increases

A Dutch biopharma trade group has proposed a summit with the government on drug price transparency in response to Minister of Health Bruno Bruins’ threat to name and shame companies that excessively raise drug prices....

FDA urged to expand on integrated review

A new FDA drug review template, part of an integrated review system unveiled in June, is raising concerns that data that would be valuable for drug development and for informing treatment decisions could be left...