Info & Opinion
June 26, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
Ted Agres of The Scientist has a very nice review of the recent machinations around drug safety. The article is an attempt to predict what will happen when the new Congress convenes.
The article suggests that details of a new drug safety environment are being worked out behind the scenes. There are no specifics. But it appears that both the industry and the FDA want additional voluntary, non-statutory guidelines about drug safety. Such measures could reduce the sense of urgency about any new laws being needed.
Here’s a quote from the story:
”[Deputy FDA commissioner Scott] Gottlieb says industry representatives have agreed to pay for increased drug safety monitoring activities at the FDA from earmarked user fees. ‘We’ve already reached some preliminary agreements with industry around certain safety provisions,’ Gottlieb says. Whether the FDA also will seek more funds from Congress won’t be known until the administration submits its Fiscal 2008 budget request next month.
Some are cynical about the relationship between Congress and the FDA. Henry Miller, a longtime critic of the agency and a former FDA official, says the agency is scared of Congressional action and is trying to preempt it with what he calls cosmetic changes such as the Drug Safety Oversight Board, created in 2005, and the Critical Path Initiative. ‘The administration and FDA will attempt to mollify Congress with more cosmetic changes and not make needed fundamental changes,’ such as revamping the agency’s drug approval mechanisms, says Miller.”