New FDA Commissioner Could Cut Regulations

Published April 23, 2017

Dr. Scott Gottlieb will lead the U.S. Food and Drug Administration (FDA) under President Donald Trump, pending confirmation by the Senate.

Trump announced his intention to nominate Gottlieb on March 10, according to a tweet by White House Press Secretary Sean Spicer.

Gottlieb is a resident fellow at the American Enterprise Institute (AEI), where he focuses on the FDA, Medicare and Medicaid, health care reform, political and clinical trends in medicine, innovation, and technology, his AEI profile states.

Under President George W. Bush, Gottlieb served as FDA deputy commissioner for medical and scientific affairs and as senior advisor to the administrator of the Centers for Medicare and Medicaid Services. A physician, Gottlieb serves on various health care and pharmaceutical-related boards.

Gottlieb argued the entry of generic drugs into the market has “sometimes been needlessly delayed” by FDA regulations, in an op-ed for Forbes in 2016. “This is largely because FDA lacks the scientific and regulatory framework to efficiently approve copies to complex drugs under its existing rules,” Gottlieb wrote. “But the Agency insists on trying to force these drugs down its traditional, misapplied, and dead-end approval routes.”

Inside Knowledge

Devon Herrick, a senior fellow at the National Center for Policy Analysis, says Gottlieb’s experience as a physician and former FDA commissioner will help the Trump administration roll back unnecessary restrictions.

“Understanding the internal workings will be an asset when he is tasked with reducing burdensome regulations and cutting unnecessary red tape,” Herrick said. “Under Trump, the FDA should seek to streamline its labyrinth of bureaucracy and patchwork of regulations.”

Myriad conflicting FDA regulations increase costs and cause unnecessary delays for drug developers bringing new products to market, Herrick says.

“Currently, drug companies and device manufactures face an impossible task just understanding what is required of them,” Herrick said. “A thorough revamping of regulations, [such as] getting rid of redundant regulations and guidance documents that conflict with other guidance documents, would improve safety by allowing firms to better adhere to requirements.”

Right-to-Try Friendly?

Christina Sandefur, executive vice president of the Goldwater Institute, says Gottlieb should respect state laws helping terminally ill patients.

“I hope he will support a federal right-to-try policy and not interfere with states that have enacted protections for terminally ill patients who want to use investigational medications,” Sandefur said. “He should support international reciprocity to help get patients in the U.S. faster access to lifesaving medications.”

Sen. Ron Johnson (R-WI) has introduced a national right-to-try bill that would ensure the effectiveness of 33 state right-to-try laws, which aim to protect from recrimination terminally ill patients, as well as their providers and drug suppliers, who use drugs not fully approved by FDA. (See interview on page 11.) Herrick says Gottlieb appreciates terminal patients’ right to experiment with last-ditch treatments, as well as drug developers’ reluctance to provide patients with drugs still being tested.

“Gottlieb is on record as favoring access to experimental drugs after desperately ill patients have exhausted other avenues,” Gottlieb said. “Yet, he also realizes drug makers are reluctant to provide drugs to patients not screened and part of closely observed clinical trials. I do not believe he would support forcing drug makers to provide experimental drugs to dying patients.”

Toward Freedom to Choose

Reducing regulation would incite competition, lower prices, and expand treatment options for all patients, Herrick says.

“The drug agency should drop foolish initiatives, like clinical trials for old, grandfathered drugs or booting them from the market,” Herrick said. “This drastically raised costs on drugs safely used for decades.”

Gottlieb should steer FDA toward allowing products safely used in Europe to enter U.S. markets, Herrick says.

“The FDA should seek to allow approvals of ingredients if approved and safely used in Europe,” Herrick said. “More than two years after the Sunscreen Innovation Act, the agency still has not approved the new generation of sunscreen ingredients used in Europe for more than a decade.”

Even FDA can’t keep track of its confusing regulations, Herrick says.

“The agency could improve public safety by simplifying regulations, making them easier to understand, and enforcing compliance,” Herrick said. “The FDA has so many regulations that the agency has a hard time enforcing them.”

Emma Vinton ([email protected]) writes from Troy, Michigan.

Internet Info:

Devon Herrick, “Analysis: Who Is Responsible for High Drug Prices?” Health Care News, The Heartland Institute, April 2017.

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