Instead he has focused on ways to move away from waiting for large, clinical trial results. Writing in Massachusetts newspaper South Coast Today last year, Gottlieb praised the 21st Century Cures Act which was signed into law in December , and said that it would help smooth the way for quicker approvals by zeroing in on results from small trials and interim study results instead of waiting for more traditional clinical trial findings.
Further insights about his views come from an article he penned in for National Affairs ,in which he criticized the FDA for setting up too many regulatory hurdles. There, too, he argued that extensive clinical trial requirements may have a chilling effect on bringing new therapies to market. He called for a fundamental change to that culture, whereby FDA employees who review the science involved in drug evaluations would delegate final approval decisions to another part of the agency or an outside group—so that the same individuals are not acting as both judge and jury.
The commissioner is intended to act as a check on the system, Gortler explains. Michael Carome, who heads the Health Research Group at a liberal nonprofit organization called Public Citizen, says having a doctor or someone with a strong science foundational is critical because the FDA is a science-based organization.
These bills come up for renewal every five years and are largely supported by lawmakers and the pharmaceutical industry, so the renewals provide opportunities for other provisions to be slipped in—including ones that may loosen rules in other areas related to medical regulation, Carome says. That reality will make those bills an attractive vehicle for lobbyists hoping to loosen other regulatory requirements, he says. Other early tests will come from how the Trump administration and the Republican-led Congress act on drug pricing issues.
The president has said that allowing more drug imports would be a key approach to lowering prices, and increasing those imports would require legislative action. That, too, may be something that could be tacked onto other legislation in the next session of Congress. Califf stepped down when Trump was sworn in. When the article was first published his nomination was not yet confirmed.
Dina Fine Maron, formerly an associate editor at Scientific American , is now a wildlife trade investigative reporter at National Geographic. Already a subscriber? Sign in. Thanks for reading Scientific American. Create your free account or Sign in to continue. See Subscription Options.
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Janet Woodcock, as President Joe Biden has struggled to find a candidate who can win Senate confirmation. It's not for a lack of trying. For months, Biden's top aides have considered several possibilities for the top job, but have ultimately come up short.
In recent weeks, the search has languished as officials decided the pushback to making Woodcock the permanent commissioner is too strong. She has come under scrutiny from critical votes like Sen.
Joe Manchin, a moderate Democrat from West Virginia, for how liberally the FDA approved opioids when she ran the drug division within the agency.
Manchin's state has been ravaged by opioid addiction. Two officials said it could be "weeks" before Biden settles on anyone. Read More. The search has been wide-ranging, with officials inside the West Wing and Biden's outside advisers all searching for possible contenders.
They have, at times, considered the acting commissioner, former Obama officials and outside public health experts. At one point, one outside adviser even reached out to Dr. Biden's White House. White House press secretary Jen Psaki said Wednesday the search remains a "priority," but Biden is waiting to find "exactly the right person.
It is a priority for him.
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