House committee adds pharma 'bad actor' provision to FDA user fee bill
A group of House lawmakers on Thursday approved the FDA user fee reauthorization bill and added a bipartisan amendment aiming to curb abusive drug pricing on pharmaceuticals without generic competition.
The amendment and the bill, both passed unanimously out of the Health subcommittee of the House Energy and Commerce Committee. The Senate version did not include that same drug pricing provision.
Rep. Kurt Schrader, D-Ore., joined forces with Rep. Gus Bilirakis, R-Fla., to write the amendment, which offers a six-month exclusive rights period generic manufacturers who choose to compete against an off-patent drug that currently has no competition. Currently, that six month exclusivity is only available to a first entrant.
Some observers have questioned whether an earlier version of the legislation, which had an additional incentive, would have any effect.
Schrader related a story from a constituent whom he said called his office and told staff that her drug, an off-patent drug owned by Valeant, went from $600 a month to $22,000 a month.
"Unfortunately, this is not the first time we've heard a story like this," he said. "We've all known for a time now this is an area Congress needed to address."
Bilirakis called Mylan's price increases for the EpiPen and Turing Pharmaceuticals' price hike for a drug for HIV patients from $13.50 a pill to $750 "unacceptable."
"Too often bad actors in the marketplace like these take advantage of monopolies," he said.
The FDA user fee reauthorization increases the levies against drug and device makers, with total fee revenue climbing from $718.7 million in this fiscal year to $878.6 million in fiscal year 2018. The fees are about 75% of the funding for both brand and generic drug review divisions, though they are a smaller proportion for biosimilars — generic-like competitors to biologic drugs — and for devices.
The reauthorization needs to pass before the end of September in order for the agency to keep functioning.
Rep. Frank Pallone (D-N.J.) said 5,000 FDA employs could be laid off if the reauthorization is delayed. The reauthorization provides funding for 230 hires at the FDA to prevent backlogs in applications.
"I was disappointed to receive a letter this week by Mr. Price," Pallone said, referring to HHS Secretary Dr. Tom Price. He said the secretary said he'd like to "recalibrate" the user fee agreement. Pallone said it took two years to negotiate the fee structure, and he urged his colleagues to "reject this last-minute plea from the administration."
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