By Deena Beasley
SAN DIEGO, June 23 (Reuters) – U.S. biotechnology industry trade group BIO worked with the Food and Drug Administration on plans announced on Monday to speed clinical trials and expects the next initiative will aim to standardize the agency’s review of drug applications, CEO John Crowley said on Tuesday.
“We need more consistency at the FDA,” Crowley said in an interview at BIO’s annual meeting in San Diego.
He said a meeting of BIO’s board of directors on Monday was focused on the growing competitive threat from China and artificial intelligence.
“We are aligned with Congress and the administration. These are bipartisan issues,” Crowley said. “Biotechnology is a national strategic asset.”
U.S. health officials announced a program on Monday “to restore America’s leadership in clinical trials” through a series of measures designed to speed drug research.
Crowley said the next big need is for standardized FDA review criteria, which can currently vary widely for drugs in different disease categories or types of molecules.
“There is uncertainty in the regulatory review process for many medicines, especially in rare diseases,” he said.
Crowley said clearer standards also need to be put in place to determine whether a drug qualifies as a breakthrough therapy or other special review class.
“The U.S. FDA needs to continue to be the gold standard in the world,” the BIO CEO said.
(Reporting By Deena Beasley; Editing by Mark Porter)
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