More than a year into U.S. President Joe Biden’s four-year term, the FDA commissioner seat remains open. While Robert Califf secured a critical endorsement Jan. 31 in his quest for a second term in the post, his hope for a sequel may still be up in the air.
U.S. FDA regulation of combination products has always been complicated, and a new final guidance takes up the long-standing controversy over FDA review of these applications. The final guidance makes explicit the possibility that the individual components of a cross-labeled combination product will be reviewed separately, a concession that industry saw as critical to ensure that these applications can make it through the FDA gauntlet without undue delay.
PERTH, Australia – A new parliamentary report, The New Frontier: Delivering better health for all Australians, is recommending significant reforms to the nation’s health care system to ensure Australians have faster access to new drugs and devices. The House of Representatives Standing Committee on Health, Aged Care and Sport examined the range of new drugs and emerging medical technologies that are in development and progressing through the regulatory system in Australia and in other countries.
While comments continue to pour in, both in opposition and support, regarding the U.S. Centers for Medicare & Medicaid Services’ (CMS) proposed national coverage decision that would restrict Medicare coverage of monoclonal antibodies intended to treat Alzheimer’s to those used in CMS- or NIH-approved clinical trials, some groups also are appealing to Health and Human Services (HHS) Secretary Xavier Becerra to step into an HHS agency turf war.
PERTH, Australia – Australia’s Therapeutic Good Administration (TGA) plans to increase all fees and charges to industry by 2.6% for the 2022 to 2023 financial year, and it is seeking feedback on proposed options.
Market pressure for M&As in the life sciences sector and the U.S. government’s determination to crack down on anything that smells of antitrust could be on a collision course this year that’s likely to result in injunctions and a lot more litigation.
LONDON – The EU’s third generation public-private research partnership in health formally got off the ground on Jan. 26, with a promise to invest €2.4 billion (US$2.7 billion) and back 30 large-scale, cross-sector innovation projects by 2030. The Innovative Health Initiative is the successor to the Innovative Medicines Initiatives 1 and 2, which between 2008 – 2020 put €5 billion into precompetitive research to accelerate translation of biomedical research to new drugs.
The European Council adopted a regulation Jan. 25 giving the EMA a stronger role in crisis preparedness and the management of drugs and medical devices during a crisis.
With U.S. merger filings more than doubling between 2020 and 2021, the Federal Trade Commission (FTC) and the U.S. Department of Justice’s (DoJ) Antitrust Division are seeking public input as they begin to modernize federal merger guidelines to better detect and prevent what they consider illegal, anticompetitive deals.
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