ACRO offers the FDA regulatory suggestions at lackluster public hearing

The Association of Clinical Research Organizations (ACRO) last week gave the FDA recommendations on how to improve drug development and clinical trial regulations, but officials wonder if the FDA will take them to heart.

"It's safe to say the FDA is under pressure from Congress and the industry to look harder at innovation and how to help foster innovation," said John Lewis, ACRO's vice president of public affairs. "That pressure may have brought ... [the hearing] about, but without a real agenda, like action items, there was a feeling that it may not have been worth it to participate."

According to an ACRO statement, executive director Doug Peddicord presented ideas that ranged from the FDA appointing a chief innovation officer with the authority to approve novel approaches to clinical trials, to testing the use of a single, central IRB to improve the quality of independent reviews. But an April 23 hearing was thrown together within 6 weeks, which didn't give ACRO a lot of time to prepare, Lewis said. It felt rushed and disorganized, lasting only one day rather than two. It was unclear to ACRO and others as to why there was a hearing at that time and what the outcome of it would be, according to Lewis. Still, despite the uncertainty, ACRO had an obligation to testify.

The FDA approval process could use sprucing. ("Dated is not a bad word," according to Lewis.) As Peddicord said in a statement, it bleeds money and time, only to produce a small handful of products. Following the example of CROs that have embraced ideas like globalization, electronic data capture, and collaboration with sponsors and regulators, the FDA can turn to innovation.

But if the FDA can't get around to making changes immediately, offering some sort of forum to bounce ideas off of is a strong step. "We know they're working on ideas," Lewis said. "There just needs to be a mechanism to go to the FDA and say 'We want to do this and what do you think?'"

- read ACRO's statement on testifying
- here's the PharmaTimes coverage