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BioCommunique Article

Witness testifies that illicit trade has increased dramatically in recent years and is a serious concern in the healthcare industry.

House Committee Holds Drug Safety Hearing

  • 2020-01-31T17:04:00.000+0000
  • Washington DC
  • Author: Brittany Blocker

On January 29, the House’s Energy and Commerce Committee held a hearing entitled “Improving Safety and Transparency in America’s Food and Drugs.” The committee considered four bipartisan priorities aimed at improving the safety of America’s drug supply, increasing transparency in the marketplace, and providing additional protection against the threat of counterfeit products. The committee heard testimonies from four witnesses: Jeff Allen, President & CEO of Friends of Cancer Research; Richard Kaeser, VP of Global Brand Protection at Johnson & Johnson (J&J); Fernando Muzzio, Distinguished Professor at Rutgers University; and Kao-Ping Chua, Assistant Professor at University of Michigan Medical School.

Kaeser testified that illicit trade has increased dramatically in recent years and is a serious concern in the healthcare industry because of the serious injuries patients can incur due to counterfeit and illicit products . According to one estimate, global trade in counterfeit goods will hit $1.9 trillion by 2023. H.R. 5663, the Safeguarding Therapeutics Act, would extend the FDA’s administrative destruction authority to medical devices and combination products valued at $2500 or less. Under current law, FDA is authorized to destroy certain imported drugs that may pose a threat to public health; however, this authority does not extend to medical devices, including some combination products. Kaeser argued that this authority is important to protect consumers, patients, and the integrity of the supply chain by preventing counterfeit products from reaching end users.

Other legislations that were discussed include:

H.R. 4866, the National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act, would direct FDA to designate higher education institutions as National Centers of Excellence, allowing FDA to work with the centers and industry to create a national framework for the implementation of continuous manufacturing technology.

H.R. 5668, the MODERN Labeling Act, which allows FDA to require modifications be made to outdated labeling for generic drugs. Generic drugs are generally required to have the same labeling as the brand drug they reference, however, once the brand drug is no longer on the market, the generic manufacturer is not able to update their label to reflect the most accurate and up-to-date information, often discovered through post-market use.

H.R. 4712, the Fairness in Orphan Drug Exclusivity Act, would update the Orphan Drug Act to require drug manufacturers that receive an orphan drug designation under the cost-recovery provision of the Act to demonstrate that successor drugs eligible for the designation do not have a reasonable expectation of recouping their research and development costs.