August 4, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – Hours before the U.S. Senate recessed for the remainder of the summer, legislators approved key legislation that will provide the necessary funding to keep the U.S. Food and Drug Administration operating efficiently.
The reauthorization bill made its way to the desk of President Donald Trump and he is expected to sign the bill, reported Focus, the publication of the Regulatory Affairs Professional Society. The Trump administration has been calling for the FDA to be funded entirely from user fees and had indicated earlier in the year it would have preferred the pharma and biotech industry to shoulder funding of the agency through higher fees. Earlier this year, the White House said industries that benefit entirely from a federal agency should pay for that agency.
With the reauthorization complete, the FDA will be able to avoid 5,000 layoffs and begin hiring for new positions to help expedite the review of new medications and devices.
The Senate overwhelmingly approved the FDA user-fee agreements by a 94 to 1 vote that allows the regulatory agency to collect user fees from pharmaceutical and biotech companies as well as medical device makers. Sen. Bernie Sanders was the lone no vote. The fees the FDA collects are used to fund the reviews of medical devices and new drugs. The FDA has been charging to review products since 1992.
Health and Human Services Secretary Tom Price said Congress was to be commended for approving the FDA Reauthorization Act of 2017. The bill authorizes the collection of fees for the next five years.
“This bill is a vital first step to accomplishing our goal of expanding access to affordable, life-saving drugs and medical devices in a thoughtful manner that protects taxpayer resources, promotes competition, improves healthcare outcomes, and stimulates scientific innovation and medical advances,” Price said in a statement.
Jim Greenwood, president and chief executive officer of the Biotechnology Innovation Organization (BIO) also hailed passage of the legislation. He called it an important victory for patients and the next generation of medical innovation.
“This legislation will advance patient involvement in drug development and bring patient perspectives more clearly to bear on regulatory decisions. It also ensures that the FDA continues to have the resources necessary to carry out its critical human drug review programs, and takes steps to modernize and improve the clinical trial process, which remains the most time-consuming, complex and expensive stage of drug development,” Greenwood said in a statement.
With the reauthorization complete, the FDA will be able to avoid layoffs and begin hiring for new positions to help expedite the review of new medications and devices.
Modern Healthcare reported the FDA will take in approximately $9 billion in user fees ($8 billion from pharmaceuticals and $1 billion from devices) through 2022, when Congress will be called upon to authorize and new agreement.
Some of the provisions for the Senate’s reauthorization act include “right to try legislation” that would allow terminally ill patients to receive experimental treatments that have yet to be approved by the FDA. The legislation also calls for more transparency from the FDA regarding the inspection of drug and device manufacturing facilities. The bill calls for the legislation to be published annually – including the amount to time between steps in the inspection process, RAPS reported.
Modern Healthcare also noted that the bill includes the Research to Accelerate Cures and Equity for Children Act. That legislation would “eliminate exemptions that allow drug and device developers to forgo pediatric studies of certain molecularly targeted cancer drugs.” Supporters of the legislation say the act will spur the pharmaceutical industry to develop newer and more effective pediatric oncology treatments.
