Politics, Policy & Law

DiLenge predicts biopharma companies will ‘take a hit’ in infrastructure bill

As he prepares to leave BIO after 15 years, Tom DiLenge previewed the urgent policy challenges the industry will face in the coming months, including pending drug price control legislation that could reshape...

Biden asks Congress to create DARPA-like health research agency

President Joe Biden’s FY22 budget request includes $6.5 billion to create an Advanced Research Projects Agency for Health. It also asks for a $2 billion increase in NIH funding that would bring the total to...

CBO report supports biopharma view of value of M&A

A Congressional Budget Office report on R&D in the pharmaceutical industry released Wednesday charts dramatic increases in industry investment on R&D and links the trend to an increase in the number...

BIO 3.0: Reinventing the trade association

BIO is rebooting itself, creating what could be called BIO 3.0, the third reimagination of the organization following the paths charted by Carl Feldbaum, who led it from 1993 to 2005, and Jim Greenwood,...

Abernethy tackled ‘the blooming obvious’ at FDA by improving tech and data

When Amy Abernethy joined FDA as principal deputy commissioner, “there were two things that were just blooming obvious,” she told BioCentury as she prepared to wind up a two-year stint at the agency....

Democrats’ latest drug pricing bills reflect Sanders’ rhetoric

Sen. Bernie Sanders (I-Vt.) Tuesday accused drug companies of “getting away with murder,” asked rhetorically “how many people need to die before Congress takes on the greed of the pharmaceutical industry?” and introduced legislation that...

Twilight of HHS sunset rule

The Biden administration has taken a dim view of a Trump administration rule that sought to automatically terminate, or sunset, all HHS rules unless they had undergone an extensive review. In an announcement that it...

Becerra’s confirmation, O’Connell nomination spotlight FDA commissioner choice

The Senate confirmation of Xavier Becerra as HHS secretary and President Joe Biden’s announcement that he will nominate Dawn O’Connell as HHS assistant secretary for preparedness and response shine a bright...

CMS drops plan to erode Medicare Part D protections, retains generic, biosimilar incentives

Citing “stakeholder feedback and other considerations,” CMS has jettisoned a Trump administration plan that would have allowed Medicare Part D plans to avoid covering drugs in protected therapeutic classes starting in 2022. The initial version...

FTC’s ‘aggressive’ new approach to pharma merger regulation will include biotech M&A

Under the Biden administration, the U.S. Federal Trade Commission will more aggressively investigate, and may block, proposed mergers of pharmaceutical companies. While mergers of large drug companies will be subject to intensified scrutiny, the commission...

PDUFA VII to feature $4M fee, focus on cell, gene therapies

FDA and biopharma industry representatives have agreed on most elements of the next Prescription Drug User Fee Act deal, including an increase in the application fee to about $4 million by 2027 from the current...

Congress passes American Rescue Plan with $500M for FDA’s COVID-19 activities, and billions for vaccines, testing and surveillance

The American Rescue Plan, passed Wednesday by the House of Representatives, includes $500 million for FDA’s COVID-19 activities and billions of dollars to support acquisition and deployment of vaccines, therapies and tests. President Joe Biden...

Biopharmas ask Biden to reject compulsory licensing of COVID-19 medicines

The U.S. biopharmaceutical industry is urging the Biden administration to oppose a proposal for the World Trade Organization to issue a waiver of IP protections for COVID-19 vaccines and drugs. The industry push comes ahead...

Former FDA chiefs ask Biden to name permanent commissioner

Six former FDA heads have written to President Joe Biden urging him to nominate a permanent FDA commissioner. The letter, sent Monday, does not endorse a specific candidate, but it does express confidence...

PTAB expected to get a Supreme pass

Whether the Supreme Court finds the Patent Trial and Appeal Board’s current structure to be unconstitutional may be down to a coin flip. Regardless of the outcome, it is likely that the inter partes...