More than 400 biotech leaders, including many Biotechnology Innovation Organization (BIO) members, have signed a statement condemning Friday’s ruling in a Texas federal court to block Food and Drug Administration (FDA) approval of mifepristone.
“A federal judge with no scientific training fundamentally undermined the bipartisan authority granted by Congress to the Food and Drug Administration [FDA] to approve and regulate safe, effective medicines for every American,” says the statement, which was released Tuesday.
“Judicial interference has set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry. As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval,” the statement continues.
“[M]ore than 400 leaders of some of the drug and biotech industry’s most prominent investment firms and companies” signed the statement, according to the New York Times.
The signatories include Pfizer CEO Dr. Albert Bourla and Paul Hastings, CEO of Nkarta Therapeutics and Chair of the Biotechnology Innovation Organization (BIO) Board of Directors. A wide range of BIO Board members and other member company leaders signed, including representatives from Biogen, Global Blood Therapeutics, Merck, ad Travere Therapeutics, as well as life science organizations (MassBio) and universities.
The Texas decision was suspended by a ruling in Washington State, as Bio.News reported yesterday. The Texas ruling is now being appealed by the Justice Department.
Bio.News will continue to cover this evolving story and its broader impact on the pharmaceutical industry and patients.
Former FDA Commissioner Peter Pitts discusses the broader implications of the ruling on CNBC:
