The federal budget law passed by Congress and signed by the president in late December calls on federal authorities to establish “warm base” domestic manufacturing to respond quickly to demand surges for medical products during a public health emergency.   Section 2401 of the law calls on the Biomedical Advanced Research and Development Authority (BARDA) to work with the US Food and Drug Administration (FDA) to coordinate these efforts.   The law amends Section 319...

The recently enacted omnibus spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to expand its unannounced foreign facility inspection pilot program in a quest to achieve parity with domestic inspections, which are mostly unannounced.   The FY 2023 spending bill was signed by President Biden on 27 December. The bill authorizes $3.5 billion in budget authority for FDA in FY 2023, a 6.5% increase compared to the previous ...

The recently enacted ominous spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to establish advanced manufacturing centers for excellence and an advanced manufacturing technologies designation program.   The omnibus spending bill was signed by President Biden on 27 December and authorizes $3.5 billion in budget authority for the US Food and Drug Administration (FDA) in FY 2023, a 6.5% increase compared to its 2022 bud...

Sen. Richard Burr (R-NC) continued to criticize the US Food and Drug Administration (FDA) for failing to provide lawmakers a Medical Device User Fee Amendments (MDUFA V) deal and for not publishing meeting minutes with industry on time. His comments came during the second user fee reauthorization hearing in the Senate Health, Education, Labor and Pensions (HELP) committee.   On 26 April, the directors of FDA’s medical product centers sat before the HELP committee to ...

The new medical device user fee deal includes the US Food and Drug Administration’s (FDA) total product lifecycle (TPLC) advisory program, or TAP, as well as new guidance development requirements and claw back provisions that let industry renegotiate fees. If signed into law as is, it would bring in $1.78-$1.9 billion over the next five years.   FDA finally published a commitment letter on 22 March summarizing the Medical Device User Fee Amendments (MDUFA V) deal i...

Members of the House Energy and Commerce’s Subcommittee on Health heard testimony 2 December from a US Food and Drug Administration (FDA) official urging congressional support of an administration plan to permanently place fentanyl in the most restrictive category allowed under the Controlled Substances Act (CSA).    The plan addresses the “pressing need” of the public health crisis posed by fentanyl and its related compounds by placing them by default into schedule ...

In a letter to Department of Health and Human Service (HHS) Secretary Xavier Becerra earlier this week, top Democrats on the House Energy and Commerce Committee pressed the health secretary to reverse a Trump-era policy that removed laboratory developed tests (LDTs), including those for COVID-19, from US Food and Drug Administration (FDA) oversight.   “Only FDA has the legal responsibility, as well as the experience and expertise, to evaluate the accuracy and reliabili...

In a report to Congress, the US Food and Drug Administration said that there is a public health need for additional pediatric information in labeling for over one-third of approved orphan indications that are relevant in the pediatric population. FDA research, conducted as part of the FDA Reauthorization Act of 2017  (FDARA), found that of all drugs that were approved for an orphan indication between 1 April 1999 and 31 August 2018, a total of 548 orphan indications we...

The House Appropriations Committee on Wednesday released a draft fiscal year 2020 funding bill for the US Food and Drug Administration (FDA), calling for a $184 million increase in discretionary funding over 2019’s enacted level.   Total funding for FDA, including revenue from user fees, is $5.86 billion, according to the bill. That total is slightly less than the $6.1 billion requested by the Trump Administration for FDA.   “Within this total, the Committee prov...

A bipartisan team of eight Congressional leaders are circulating a “Dear Colleague” letter to urge fellow members of Congress to permanently repeal of the 2.3% medical device excise tax before it is reinstated next year. The device tax has only been in effect for two years—between 2013 and 2015—since it was introduced in 2010 under the Affordable Care Act . From device firms and industry groups to patient advocacy groups and health research organizations, the push agai...

A recent report from the Office of the Inspector General (OIG) “highlighted some very important issues” where the US Food and Drug Administration (FDA) “has room for improvement,” Sen. Chuck Grassley (R-IA) argued in a letter to FDA Commissioner Scott Gottlieb.   The 9 November letter from Grassley, chairman of the Senate Judiciary Committee, follows on the heels of the findings and recommendations OIG at the US Department of Health and Human Services outlined in a...

Following the House’s transition Tuesday to a Democratic majority, Senate Majority Leader Mitch McConnell (R-KY) said Wednesday that he will work with House Democrats on crafting a plan to tackle high prescription drug prices.   “I can’t imagine that won’t be on the agenda,” McConnell said regarding prescription drug prices. Potential House speaker Nancy Pelosi (D-CA) also further indicated that representatives and senators on both sides of the aisle will look to find ...