It’s not enough for the CEOs of nine biopharma companies to sign a pledge committing “to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles,” according to the Democratic leadership of the U.S. House Energy and Commerce Committee.
In letters sent to the CEOs Sept. 15, Committee Chair Frank Pallone (D-N.J.) and Reps. Anna Eshoo (D-Calif.) and Diana DeGette (D-Colo.) noted that the pledge lacked a commitment to transparency or other means of accountability.
“We implore you to fulfill the commitments you made in your announcement to ensure science and safety drive the process. We also strongly encourage you to take steps to make the process more transparent in order to regain the trust and confidence of the American people in a future COVID-19 vaccine,” the lawmakers said in letters sent to the CEOs of Astrazeneca plc, Biontech SE, Glaxosmithkline plc, Johnson & Johnson, Merck & Co. Inc., Moderna Inc., Novavax Inc., Pfizer Inc. and Sanofi SA.
The letters also requested updates on the companies’ progress on a vaccine and information about how they intend to ensure that “only a safe and effective product” is made available to the public.
Originally, the pledge was signed by five CEOs in an effort to hit back against suggestions that COVID-19 vaccines and therapies could be approved in advance of phase III data. The CEOs said it is imperative the highest standards of quality, safety and efficacy are upheld everywhere.
Since its release early this month, the pledge has gained more signatures.
FDA: DMF a pathway for cannabis drugs
If sponsors developing drugs containing cannabis and cannabis-derived compounds are concerned about protecting proprietary data, they should consider the drug master file (DMF) pathway, the FDA said Sept. 16.
Used to submit confidential, detailed information about facilities, processes or articles used in manufacturing, processing, packaging and storing of human drugs, DMFs allow parties to reference material without disclosing the DMF contents. There also are no submission fees when they are used to support an investigational new drug or new drug application, the FDA said.
“It is critical that FDA continues to do what we can to support the science needed to develop new drugs from cannabis,” the agency said as it encouraged sponsors to use the DMF path.