The House Energy & Commerce health panel will review legislative proposals that aim to end gaming of the Orphan Drug Act, improve generic drug labeling and foster continuous manufacturing at a legislative hearing Wednesday (Jan. 29). The bills, which if enacted could help lower drug costs by spurring generic drug competition, are among 10 to be reviewed at the hearing, which will focus on ways to improve the safety and transparency of drugs, devices and food.
The orphan drug bill, Fairness in Orphan Drug Exclusivity Act (H.R. 4712), aims to address allegations that some drug makers are abusing the Orphan Drug Act’s market in order to gain seven years of exclusivity on their products. The bill would make it more difficult for drug manufacturers to receive orphan drug designation.
The long-standing orphan drug law was enacted to incentivize the development of drugs for rare disorders by helping drug makers recoup development and research costs.
But after the maker of a buprenorphine product made billions off the law, Reps. Madeleine Dean (D-PA), Marc Veasey (D-TX), Buddy Carter (R-GA) and David McKinley (R-WV) introduced H.R. 4712 to try to stop such gaming. The bill would reform the Orphan Drug Act to require drug manufacturers seeking orphan drug designation to annually demonstrate the absence of an ability to recoup costs from research and development during the seven-year market exclusivity period.
The health panel also will consider a bill that aims to foster use of continuous manufacturing by the drug industry. The National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act (H.R. 4866), introduced by E&C Chair Frank Pallone (D-NJ) and Rep. Brett Guthrie (R-KY), would reform the 21st Century Cures Act by directing FDA to create National Centers of Excellence in Continuous Pharmaceutical Manufacturing (NCEs) to help further the development of continuous drug manufacturing. It also would designate $80,000,000 toward NCEs from 2021 to 2025.
The NCEs would work in conjunction with FDA and industry to create a national framework detailing research, standardization and collaboration to help foster continuous manufacturing.
FDA drug center chief Janet Woodcock has encouraged the development of continuous drug manufacturing as a way to reduce American reliance on foreign drugs and to avert safety issues that result in drug shortages and recalls. But the generic drug industry has been hesitant to endorse the process.
Also to be taken up is a bill that would give FDA authority to mandate generic drug makers update their labels with new information, such as safety problems and new uses, in cases when a brand label lapses. Generic drug labeling approved by FDA is required to have the same labeling as the comparative brand drug, but currently generic drug makers cannot independently update their labeling if there is no longer an active brand label. The Making of Drug Objective Evidence Revisions for New (MODERN) Labeling Act of 2020 (H.R. 5668), introduced by Guthrie and Rep. Doris Matsui (D-CA), also would require FDA to report any updates to labeling under the new legislation.
The panel will also review the Safeguarding Therapeutics Act (H.R. 5663), which would give FDA authority to seize and destroy counterfeit medical devices exported into the United States. The bill, introduced by Guthrie and Rep. Eliot Engel (D-NY), would extend the agency’s existing authority to destroy certain imported drugs that pose a threat to consumer safety to also include devices.
The health subcommittee will also hear from experts on the following food-related bills:
Safeguard American Food Exports Act of 2019 (H.R. 961)
The bill would prevent the interstate or foreign export of equines or equine parts intended for human consumption. Reps. Jan Schakowsky (D-IL) and Vern Buchanan (R-FL), the sponsors of the bill, deemed equine parts as unsafe for human consumption due to the animals being routinely treated with phenylbutazone.
DAIRY PRIDE Act (H.R. 1769)
The Defending Against Imitations and Replacements of Yogurt, Milk, and Cheese to Promote Regular Intake of Dairy Everyday (DAIRY PRIDE) Act, proposed by Rep. Peter Welch (D-VT), seeks to clarify the definition of a dairy product and prohibit marketing food that does not meet this definition as “dairy”.
To qualify as a dairy product, the food must either be, contain a primary ingredient from, or be derived from the lacteal secretion from the complete milking of one or more hooved mammals.
FASTER Act of 2019 (H. R. 2117)
Matsui introduced the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2019 to update allergen information. This includes requiring the Centers for Disease Control and Prevention (CDC) to expand its collection of allergen information, amending the Federal Food, Drug, and Cosmetic Act to include sesame as a major allergen, and allowing FDA to add other food ingredients to the list of major allergens if needed.
Infant Formula Protection Act of 2019 (H.R. 2267)
Infant formula is currently defined as adulterated if it does not provide proper nutrition, does not meet quality factor requirements, or its processing does not comply with quality process and procedures.
The Infant Formula Protection Act of 2019, introduced by Reps. Grace Meng (D-NY) and Annie Kuster (D-NH), would amend food and drug law to also define infant formula as adulterated if the sell-by date has passed.
Keep Food Containers Safe from PFAS Act of 2019 (H.R. 2827)
Rep. Debbie Dingell’s (D-MI) Keep Food Containers Safe from PFAS Act of 2019 would amend food and drug law to state that manmade chemicals, known as perfluorinated substances (PFAS), are unsafe when used in food contact substances beginning in 2022.
PFAS has been found in cleaning products, cookware and food containers. The chemical is linked to several adverse medical conditions such as cancer, liver disease and reproduction problems.
CURD Act (H.R. 4487)
The Codifying Useful Regulatory Definition (CURD) Act would amend food and drug law to clarify the definition of a natural cheese product. Reps. Ron Kind (D-WI), Billy Long (R-MO) and Kurt Schrader (D-OR), the sponsors of the bill, hope to distinguish the difference between a natural cheese product and pasteurized processed cheese.
Under the bill, natural cheese would be recognized as cheese produced by coagulating the protein of milk, skimmed milk, partly skimmed milk, cream, whey cream, or buttermilk, or any combination of such ingredients as cheese produced by coagulating the protein of milk, skimmed milk, partly skimmed milk, cream, whey cream, or buttermilk, or any combination of such ingredients.
This bill would also prohibit the sales of pasteurized cheese under the marketing guise of natural cheese.
The subcommittee will hear testimony from the following: Jeff Allen, president and CEO of Friends of Cancer Research; Richard Kaeser, vice president of global brand protection for Johnson & Johnson; Fernando Muzzio, distinguished professor of chemical and biochemical engineering at Rutgers; Kao-Ping Chua, assistant professor in the department of pediatrics at the University of Michigan Medical School; Melanie Benesh, legislative attorney for the Environmental Working Group; Tom Balmer, executive vice president for the National Milk Producers Federation; and J. David Carlin, senior vice president of legislative affairs and economic policy for the International Dairy Foods Association.