Politics, Policy & Law

Wyden makes opening move in latest drug pricing game

Releasing a set of principles for drug pricing reform, Sen. Ron Wyden (D-Ore.) Tuesday made the opening move in what is certain to be a complex and lengthy legislative chess match. Wyden, chairman of the...

21st Century Cures 2.0 includes ARPA-H, antibiotics incentives, real-world evidence

Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) Tuesday released a discussion draft of the 21st Century Cures Act 2.0 that seeks to establish a new agency to fund breakthrough medical research, create market incentives...

ARPA-H plan advances with mission, legislation

Newly released details of the Biden administration’s proposed Advanced Research Projects Agency for Health map out a mission for the new entity to support breakthrough technologies and make clear that...

Supreme Court chooses surgical fix for PTAB case, leaving IPR process largely unchanged

The Supreme Court’s decision to make all subsequent Patent Trial and Appeal Board cases subject to review by the USPTO director will change little about the inter partes review system.  The inter partes review (IPR)...

Opponents use aducanumab approval to try to derail Woodcock nomination as FDA commissioner

Long-time opponents of Acting FDA Commissioner Janet Woodcock cited the accelerated approval of Biogen’s aducanumab for Alzheimer’s disease in letters urging President Joe Biden not to nominate her to the job on a permanent basis....

Lawmakers reintroduce PASTEUR Act to incentivize antimicrobial development

As industry continues to create “push” mechanisms to fund antimicrobial development, lawmakers in the U.S. Senate House of Representatives have reintroduced legislation that proposes complementary “pull” incentives to provide more revenue certainty on the commercial side.  This...

GAO report on DTC spending fuels bipartisan call for pricing disclosures

Responding to a Government Accountability Office report on direct-to-consumer advertising of drugs, Sen. Dick Durbin (D-Ill.) and Sen. Chuck Grassley (R-Iowa) Thursday said they plan to reintroduce legislation seeking to require pharmaceutical companies to disclose...

Former BIO CEO Greenwood warns of “worst of times” for biopharma in Washington

As co-leader of a new life sciences policy and regulatory practice at DLA Piper, a law and lobbying firm, Jim Greenwood, former CEO and president of BIO and a former member of Congress, hopes to...

Peter Bach, Craig Garthwaite argue Medicare should run its own aducanumab trial to guide reimbursement

With uncertainty looming over the clinical benefit and cost impact of Biogen’s newly approved aducanumab, Peter Bach and Craig Garthwaite argue in a Bloomberg Opinion piece that Medicare should run...

Industry and policymakers must embrace pragmatic drug pricing reforms: Guest Commentary

Simply wishing that drug pricing reforms won’t happen will only lead to draconian solutions imposed upon industry that undermine the long-term interests of the U.S. public and global health. The biotech...

FDA’s Cavazzoni says conflict-of-interest rules limit expertise on advisory committees

FDA’s Center for Drug Evaluation and Research and BIO have launched separate initiatives aimed at injecting more relevant expertise into the FDA advisory committee process and making the meetings more focused on science and less...

Hastings elected BIO chair, to continue reinvention of the trade association

With the election of Paul Hastings as chair of its board of directors, BIO is signaling its determination to continue a reinvention of the trade association that started two years ago with the election of...

A National Coverage Decision would be CMS’s route to limited but equitable aducanumab coverage

Questions about reimbursement and market access are on everyone’s mind now that aducanumab is approved for Alzheimer’s disease, but there’s a long road ahead to figure out how the drug and its...

BARDA is venturing into global health security

The U.S. government has launched BARDA Ventures, the first foray into venture capital for HHS, with a promise to put $100 million to $1 billion to work to strengthen global health security.  Biomedical Advanced Research and...

Lander sworn in, challenged to revamp U.S. science, tech policy

Vice President Kamala Harris Wednesday swore in Eric Lander as director of the Office of Science and Technology Policy, a role President Joe Biden has elevated to cabinet status, endowing its director...