The House Energy & Commerce Committee on Wednesday (July 15) passed five bipartisan FDA policy bills that would increase the agency’s authority over imported counterfeit medical devices, stop gaming of certain orphan drug exclusivity provisions, boost use of continuous manufacturing, empower FDA to require labeling updates for generic drugs, and allow the agency to add food ingredients to the list of major allergens.
All bills cleared the committee by voice vote.
Among a slate of 30 bipartisan bills the full committee considered on Wednesday, five address FDA’s drug, device and food authorities.
The Fairness in Orphan Drug Exclusivity Act (H.R. 4712), by Reps. Madeleine Dean (D-PA), Marc Veasey (D-TX), Buddy Carter (R-GA) and David McKinley (R-WV), would amend the cost recovery prong pathway under the Orphan Drug Act to require drug makers seeking orphan drug designations to demonstrate they don’t expect to recoup development costs.
The cost recovery prong has been used only three times to grant orphan drug designation, with two of the designations going to profitable buprenorphine-based products. Experts previously argued that, had it not been for pushback in 2019, the designation would have blocked all buprenorphine products from the market until 2024.
During E&C’s markup on Wednesday, Rep. Michael Burgess (R-TX) cautioned that revoking a benefit that’s already been awarded is a “slippery slope” and could chill innovation if more broadly adopted. However, he added, the language in the bill is narrowly tailored and doesn’t directly impact the licensure of products that currently benefit from incentives under the cost recovery pathway.
“We don’t want uncertainty caused by Congress retroactively legislating to discourage truly innovative drugs from coming to market, especially in the rare disease community. However, I think we are taking a step in the right direction by closing this loophole and preventing future abuses of the Orphan Drug Act,” Burgess said.
Veasey added that the bill will help expand access to a wide range of medication-assisted treatment and allow for innovative treatments for opioid use disorder.
E&C passed the bill with an amendment that would direct FDA to take into consideration the sales of all drugs made by the manufacturer under the same orphan drug designation. The amendment resolves some differences between the House bill and the Senate’s bipartisan companion bill, which was introduced in February.
The National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act (H.R. 4866), by E&C Chair Frank Pallone (D-NJ) and Rep. Brett Guthrie (R-KY), would direct FDA to designate National Centers of Excellence in Continuous Pharmaceutical Manufacturing (NCEs) with the aim of increasing use of continuous manufacturing in drug development. NCEs would work with FDA and industry to craft a national framework for continuous manufacturing. The bill would authorize $80 million to be appropriated for NCEs each year from fiscals 2021 through 2025.
“Continuous manufacturing is really essential, and I think that this bill is going to advance this but it also is going to advance the United States really taking back what it should be manufacturing in our own country,” E&C health subcommittee Chair Anna Eshoo (D-CA) said.
The committee passed the bill with no amendments.
The Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act (H.R. 5668), by Guthrie and Rep. Doris Matsui (D-CA), would give FDA authority to make drug companies update generic drug labeling.
“Prescription drug labels are the most readily available and trusted sources of drug information … Modern generic drug labels are key to optimizing use, enhancing patient benefit and facilitating greater use of lower cost generics,” Matsui said.
E&C passed the bill with an amendment that clarifies FDA must consider new, available and different information about a drug when deciding whether the drug needs labeling updates, and that nothing in the bill relieves sponsors of their responsibility to update drug labels when new information comes to light.
The Safeguarding Therapeutics Act (H.R. 5663), by Guthrie and Rep. Eliot Engel (D-NY), would allow FDA to seize and destroy counterfeit medical devices that are refused admission at the border, if the devices are valued at an amount less than $2,500 or any higher amount set by the Department of the Treasury.
E&C passed the bill with an amendment that clarifies the definition of a counterfeit medical device.
The Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2019 (H.R. 2117), by Matsui, would require the Centers for Disease Control and Prevention to expand its collection of allergen information, amend the Food, Drug and Cosmetic Act to include sesame as a major allergen, and allow FDA to add other food ingredients to the list of major allergens if needed.
A food advocacy organization that helped craft the bill previously told Inside Health Policy that the FASTER Act could help foster new therapies for food allergies.
However, a consumer advocate said the bill is too vague about what data should be collected.
Eshoo said passage of FASTER is a priority for her.
“I had contacted the FDA to see if this could be done administratively and here was their answer: It would take them approximately seven years to do this,” Eshoo said. “So, needless to say, I wasn’t very pleased with that, and Congresswoman Matsui took up the legislation … I think we’ve proven we can speed past the FDA by passing this legislation.”
The FASTER Act passed with no amendments.