US Representatives From Ohio, New Hampshire Write Bipartisan Letter to FDA Warning of Potential DSCSA Problems

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The act is currently set to go into effect in just over three months.

With the Drug Supply Chain Security Act (DSCSA) currently on track to go into full effect on November 27, 2023, concerns about supply chain issues and drug shortages are widespread. On that date, “manufacturers, distributors, and pharmacies—'dispensers,’ in DSCSA parlance—must be able to track, trace, and verify down to the unit level every prescription product they handle and maintain those records for a minimum of 6 years.”1

Recently, two US Representatives penned a letter2 to the FDA saying they are concerned about potential disaster if the FDA does not step in and extend the deadline for DSCSA.

Troy Balderson (R-OH) and Ann Kuster (D-NH) are the architects of the letter, but were joined by over 25 other representatives—both Democrats and Republicans—from around the country as well.

The reps say early in the letter that they do believe DSCSA will serve a positive purpose in the pharmacy community.

"Further efforts required by the DSCSA will ultimately improve the ability to trace pharmaceutical products and remove potentially dangerous products from the pharmaceutical supply chain.”

But while the purpose of DSCSA is clear, Balderson and Kuster then say that the current deadline is a sufficient timeline, and could lead to more problems than it solves in the beginning.

“It is our understanding,” the letter states in part, “That some supply chain participants are facing difficulties meeting DSCSA’s full implementation requirements. Based on what we are hearing from healthcare supply chain stakeholders about readiness for the November 27th deadline, absent government intervention, there will likely be disruptions that could lead to patient access problems and further drug shortages.”

The main problem, they explain, will be continued shortages of prescription drugs, a shortage that many individuals cannot afford, as many of those drugs are necessary for their health.

“Effective November 27, 2023, products that are not DSCSA compliant cannot be sold, distributed, nor can they be dispensed to patients. Those non-compliant products will include legitimate prescription drugs whose products do not have corresponding serialized electronic data records.”

According to Rep. Balderson’s website, this letter has garnered support from many organizations within pharmacy, including “Healthcare Distribution Alliance (HDA), American Pharmacists Association (APhA), National Association of Boards of Pharmacy (NABP), National Community Pharmacists Association (NCPA), and National Association of Chain Drug Stores (NACDS).”1

Many questions still remain regarding DSCSA and the community’s readiness for the act to pass in 3 months.

DSCSA and DQSA (part one of the act) were originally created in response to a 2012 incident at the now-closed New England Compounding Center.

“In 2012, 753 patients in 20 states were diagnosed with a fungal infection after receiving injections of preservative-free methylprednisolone acetate (MPA) manufactured by NECC,” says the FDA. “Of those 753 patients, the U.S. Centers for Disease Control and Prevention (CDC) reported that 64 patients in nine states died. The government has since identified a total of 793 patients throughout the country harmed by NECC’s contaminated steroids.”

References

1. Balderson, Kuster Warn FDA of Looming Drug Supply Chain Disruptions. Press release. Published August 1, 2023. Accessed August 14, 2023. https://balderson.house.gov/news/documentsingle.aspx?DocumentID=2533
2. Gebhardt F. DSCSA is coming. Are you Ready? Drug Topics. Published June 2023. Accessed August 14, 2023. https://www.drugtopics.com/view/dscsa-is-coming-are-you-ready-
3. January 31, 2018: New England Compounding Center Pharmacist Sentenced for Role in Nationwide Fungal Meningitis Outbreak. Food and Drug Administration. Published January 31, 2019. Accessed August 14, 2023. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/january-31-2018-new-england-compounding-center-pharmacist-sentenced-role-nationwide-fungal
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