In the second of two hearings before the U.S. Senate Health, Education, Labor and Pensions Committee on the next iteration of the FDA drug and device user fee agreements, the focus was supposed to be on advancing regulation and innovation. But Ranking Member Richard Burr (R-N.C.) shifted the spotlight April 26 to accountability in his opening remarks and subsequent questioning.
Making it a done deal, the European Council adopted proposals April 12 to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland and to address supply concerns in Cyprus, Ireland and Malta, which historically have been dependent on drugs from the U.K.
When it comes to lowering U.S. drug prices, Congress has a lot of options among the several bills that have been introduced in both the House and Senate over the years. But a deadlock between bipartisan measures and partisan proposals has reduced legislative action to mere talk. The deadlock, and the at times hyperbolic debate, continued in yet another congressional hearing March 16 on “the urgent need to lower drug prices in Medicare,” as the Senate Finance Committee billed it.
The bipartisan PREVENT Pandemics Act, which seeks to put into U.S. law many of the lessons learned from the COVID-19 pandemic, marked its first milestone March 15, with the Senate Health, Education, Labor and Pensions (HELP) Committee sending it to the full Senate with a do-pass recommendation on a 20-2 vote.
2023 may be a pivotal year for biosimilars in the U.S. with a number of approved Humira (adalimumab) biosimilars set for staggered launches under agreements with Abbvie Inc. How successful those launches are, including the launch of Boehringer Ingelheim GmbH’s interchangeable, Cyltezo, and potential other interchangeables, will be determined in large part by three pharmacy benefit managers that together control the prescription drug formularies for nearly 80% of Americans covered by Medicare and private insurance.
The potholes in the U.S. FDA’s accelerated approval path could be paved over by a bill introduced in Congress this week. Rep. Frank Pallone (D-N.J.), chair of the House Energy and Commerce Committee, introduced the Accelerated Approval Integrity Act March 8 to keep the path open to innovative drugs where there is unmet need while streamlining the process for taking drugs off the market when they don’t prove clinical benefit in a timely manner.
It’s been seven years since economist Jim O’Neill began his review on antimicrobial resistance, commissioned by the U.K. government to find ways to encourage development of badly needed new antibiotics. Since then, the pandemic has produced radical changes in society and forced pharma to refocus its R&D priorities at short notice. But COVID-19 has also raised awareness about the devastating effect that rogue pathogens can pose to society, and there are now serious moves to prevent a global catastrophe caused by antibiotic resistant bacteria.
Biopharma is getting another reprieve, as Canada once again delays the implementation of major changes to its Patented Medicines Regulations. Set to take effect Jan. 1, the implementation of the drug pricing changes has now been pushed back to July 1.
The EU is on its way to becoming one of the first to implement a historic global tax reform agreement, setting a minimum effective tax rate of 15% for large multinational groups, including biopharma and med-tech companies.
With the $2 trillion Build Back Better spending bill held up in the U.S. Senate, President Joe Biden took to his public microphone Dec. 6 to call on senators to pass the bill that will permit Medicare negotiation of certain prescription drug prices, impose an excise tax on drug companies that raise the price of their products beyond inflation and set a monthly cap on cost-sharing for insulin.
