FDA Chief Sidesteps Questions About Trump's Proposed Agency Budget Overhaul -- Update

By Thomas M. Burton Features Dow Jones Newswires

The new commissioner of the Food and Drug Administration testified before a Senate panel Tuesday without directly addressing the Trump administration's proposal to cut $700 million in taxpayer funding from its budget.

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The administration calls for making up the difference by raising fees on the pharmaceutical and medical device industries.

After senators of both parties called the Trump budget "not feasible" and "woefully inadequate," Dr. Scott Gottlieb ducked the issue by saying only, "We can always meet more with more." Later, he added, "I wasn't involved in the formulation of the budget."

The Trump administration's budget proposal, released in May, would leave a hole of more than $700 million in the $5.1-billion FDA budget compared to this fiscal year, because the document assumes about $1.2 billion in revenue for fiscal 2018 that won't turn up if Congress has its way. About $127 million of the shortfall would go toward safety surveillance of drugs and devices.

The administration has proposed raising user fees paid by the drug and medical-device industries to the agency for new-product reviews to offset the proposed cut in taxpayer funding. But those fees have already been negotiated between the FDA and industry at much lower levels, and Republican legislators have made clear they have no intention of insisting the FDA reopen talks to try to raise them.

On Tuesday, Dr. Gottlieb testified before the subcommittee of the Senate Appropriations Committee that oversees the FDA's budget.

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At the outset of Tuesday's hearing, subcommittee chairman Sen. John Hoeven (R., N.D.) said the administration's estimate of new user fees is "not feasible." Sen. Patrick Leahy (D., Vt.) called the Trump plan "woefully inadequate."

Dr. Gottlieb's prepared testimony focused on his plans at the FDA to speed up the approval of so-called orphan drugs. These are medicines for rare diseases, and Dr. Gottlieb disclosed that the agency has had a backlog of requests for orphan status that the FDA hasn't responded to.

He said the FDA has a backlog of about 200 such applications, on which the agency hasn't yet responded to companies. He told the committee that he plans for the agency in 90 days to "completely eliminate this backlog of requests and provide an answer back to the sponsors."

"Moreover, we won't ever again develop a backlog," he told senators in the prepared testimony.

The new commissioner has previously spoken about working toward speeding certain generics to market in an effort to rein in drug prices. In Tuesday's testimony, he spoke of updating guidance that the agency issues "so that we can make clinical trials more efficient." He wasn't specific as to how that would work, and many Democrats have expressed skepticism, suggesting such efficiency would lower safety standards.

In one instance, Dr. Gottleib said in Tuesday's testimony that the agency is considering broad approvals for cancer drugs that hit the same genetic or molecular targets in a variety of cancers, instead of insisting on approvals for one cancer at a time.

Write to Thomas M. Burton at tom.burton@wsj.com

WASHINGTON -- The new commissioner of the U.S. Food and Drug Administration testified before a Senate panel Tuesday without directly addressing the Trump administration's proposal to cut $700 million from its budget.

The administration calls for making up the difference by raising fees on the pharmaceutical and medical-device industries.

After senators of both parties called President Donald Trump's proposed budget "not feasible" and "woefully inadequate," Dr. Scott Gottlieb, the agency's new commissioner, ducked the issue by saying only, "The bottom line is we can always do more with more when it comes to the resources that the agency has." Later, he added, "I wasn't involved in the formulation of the budget."

Mr. Trump's budget proposal, released in May, would leave a hole of more than $700 million in the $5.1-billion FDA budget, compared with this fiscal year, because the document assumes about $1.2 billion in revenue for the coming fiscal year that won't turn up if Congress has its way. About $127 million of the money that would be cut from the budget is for safety surveillance of drugs and devices.

The administration has proposed raising user fees paid by the drug and medical-device industries to the agency for new-product reviews to offset the proposed cut in taxpayer funding. But those fees have already been negotiated between the FDA and the industries at much lower levels, and Republican legislators have made clear they have no intention of insisting the FDA reopen talks to try to raise them.

On Tuesday, Dr. Gottlieb testified before the subcommittee of the Senate Appropriations Committee that oversees the FDA's budget.

At the outset of Tuesday's hearing, subcommittee chairman Sen. John Hoeven (R., N.D.) said the administration's estimate of new user fees is "not feasible." Sen. Patrick Leahy (D., Vt.) called Mr. Trump's plan "woefully inadequate."

Dr. Gottlieb's prepared testimony focused on his plans at the FDA to speed up the approval of medicines for rare diseases, known as orphan drugs. Dr. Gottlieb disclosed that the agency has had a backlog of requests for orphan status, a designation that offers benefits to the drug's sponsor, such as tax credits.

He said the FDA hasn't yet responded to about 200 applications from companies seeking orphan status. During the next 90 days, the agency plans to "completely eliminate this backlog of requests and provide an answer back to the sponsors," Dr. Gottlieb said.

"Moreover, we won't ever again develop a backlog," he said.

The new commissioner has previously spoken about working toward speeding certain generic drugs to market in an effort to rein in drug prices. In Tuesday's testimony, he spoke of updating guidance that the agency issues "so that we can make clinical trials more efficient."

He wasn't specific as to how that would work, and many Democrats have expressed skepticism, suggesting such efficiency would lower safety standards.

In one instance, Dr. Gottlieb said the agency is considering broad approvals for cancer drugs that hit the same genetic or molecular targets in a variety of cancers, instead of insisting on approvals for one cancer at a time.

Write to Thomas M. Burton at tom.burton@wsj.com

(END) Dow Jones Newswires

June 20, 2017 17:48 ET (21:48 GMT)