Ironically, one of the casualties of the COVID-19 pandemic is an overdue review and revision of U.S. dual use research of concern (DURC) policies, as well as the Department of Health and Human Services’ Potential Pandemic Pathogen Care and Oversight guidance. Consequently, several senators are asking the White House to halt all ongoing and new viral gain-of-function and DURC studies in the life sciences that involve enhanced pathogens of pandemic potential.
Ironically, one of the casualties of the COVID-19 pandemic is an overdue review and revision of U.S. dual use research of concern (DURC) policies, as well as the Department of Health and Human Services’ Potential Pandemic Pathogen Care and Oversight guidance. Consequently, several senators are asking the White House to halt all ongoing and new viral gain-of-function and DURC studies in the life sciences that involve enhanced pathogens of pandemic potential.
Ironically, one of the casualties of the COVID-19 pandemic is an overdue review and revision of U.S. dual use research of concern (DURC) policies, as well as the Department of Health and Human Services’ Potential Pandemic Pathogen Care and Oversight guidance. Consequently, several senators are asking the White House to halt all ongoing and new viral gain-of-function and DURC studies in the life sciences that involve enhanced pathogens of pandemic potential.
The U.S. House of Representatives has resurrected the Pre-approval Information Exchange (PIE) Act, a bill that would bolster the prospects for drugs and devices by improving communications with payers prior to U.S. FDA clearance or approval of the product.
The U.S. House of Representatives has resurrected the Pre-approval Information Exchange (PIE) Act, a bill that would bolster the prospects for drugs and devices by improving communications with payers prior to U.S. FDA clearance or approval of the product. The supporters of the legislation, a bipartisan group of members of the House Energy and Commerce (E&C) Committee, see the legislation as essential as a means of overcoming some of the ambiguities in a 2018 FDA guidance pertaining to communications between manufacturers and payers, and thus a replay of one of the more interesting methods of critiquing an FDA guidance.
Election day has come and gone in the U.S., but the question of which party will control Congress remains unanswered, signaling that the country is as divided as ever politically and ideologically. While Democrats and Republicans may agree on problems in the life sciences sector, they often disagree on how to address them.
With only a week to go before the Nov. 8, 2022 midterm election in the U.S., speculation is growing over what the 118th Congress will look like and what it will mean for the biopharma and med-tech industries. If Republicans flip either chamber, it would prevent either party from using the reconciliation process, which requires the barest majority in the Senate, to pass legislation such as the Inflation Reduction Act with its provisions giving the federal government some control over prescription drug prices.
The U.S. FDA’s interest in regulating lab-developed tests (LDTs) occasionally prompts the agency to engage in a little saber-rattling about rulemaking if Congress should fail to pass legislation granting the FDA explicit authority to regulate these tests.
The U.S. Congress has reauthorized several user fee programs at the FDA, and the agency has published the user fee levels for several product types, with most of those fees increasing significantly, an example of which is the increase for new drug applications (NDAs) requiring clinical data from $3.12 million to $3.24 million. Fees for medical device premarket approval (PMA) filings will jump from $375,000 to $442,000, including some hefty adjustments for persistent inflation, a problem that may plague the user fee schedules for fiscal 2024 as well.
The U.S. Congress has finally managed to pass legislation that reauthorizes several FDA user fee programs, but the final vote came on the last day of the federal fiscal year and addressed a stripped-down version of previous user fee bills. While several key considerations survived the shift to a lean bill, the FDA will have to wait for another day to be authorized to regulate lab-developed tests and to revise the accelerated approval program for pharmaceuticals, measures that may be revisited before the end of the current calendar year.
