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  1. Regulatory News, Stories, and Features

Safeguarding Communities and National Drug Stockpiles


By: Monique Richards 

New York Medical Products Laboratory team
Chemists at ORA’s New York Medical Products Laboratory.
Pictured Left to Right: Muhammad Alaf, David Laguerre, Paula Grier and Teneka Jean-Louis

ORA’s New York Medical Products Laboratory is safeguarding the health and well-being of communities by analyzing medical products for suspected health fraud and testing products for potential issues.  The office also ensures that critical drugs in the National Strategic Stockpile are safe and ready by recommending extending the expiry date of drugs tested by the FDA. 

Preventing waste and extending a product’s shelf-life

Manufacturers of prescription drugs and over-the-counter drugs, such as those found in local pharmacies and grocery stores, are required to submit testing data, proposed expiration dates, and storage condition information to the FDA, prior to drug approval. This information helps to provide confidence that the product will meet the agency’s standards of strength, quality, and purity, throughout the product’s shelf-life. 

Chemists at ORA’s New York Laboratory Medical Products (NYLMP) work to ensure the safety and efficacy of such medical products by analyzing and sampling products, and in unique occasions, extending the expiration dates for a limited number of drug products under the Shelf-Life Extension Program, also known as SLEP. 

Under SLEP, medical products can be extended beyond their labeled expiration dates once they are tested by ORA for stability, identity, strength, quality, and purity, and are properly stored according to their labeled storage conditions. Extending a product’s shelf-life once it is tested for safety and efficacy helps to prevent waste and ensures that important medical products are available during a public health emergency. 

Stockpiles of critical medications

For example, some federal agencies have strategic national stockpiles to help during public health emergencies, such as an earthquake or a disease outbreak. Given the number of Americans reliant upon such resources during a crisis, these strategic national stockpiles may hold a large number of medical supplies and medications. Expiration dates can present challenges to agencies with stockpiles because products that have reached their labeled expiration date, in most cases, cannot be used. 

To help with this issue, staff at NYLMP regularly test prescription drugs in these stockpiles to see if they can be used beyond their expiration date. Staff at the Irvine Medical Products Laboratory in California, the Detroit Medical Products Laboratory in Michigan and the San Juan Laboratory in Puerto Rico also conduct SLEP testing. Through testing and the SLEP program, agencies can ensure that emergency products are safe and on hand, ready to be delivered to communities when emergencies strike. 

Through rigorous testing, the medical products that we test through the Shelf-Life Extension Program ensures that these products are safe, effective, and will perform as their intended use,” says chemist Lieutenant Muhammad Altaf.

“Through rigorous testing, the medical products that we test through the Shelf-Life Extension Program ensures that these products are safe, effective, and will perform as their intended use,” says chemist Lieutenant Muhammad Altaf. “SLEP saves taxpayer dollars by reducing the need for frequent stockpile replacements, while ensuring the safety profile of stockpile medications. In times of emergencies, outbreaks, and adverse events, our team play a crucial role in responding promptly to assess risks and mitigate potential harm to the public while helping to ensure the well-being of communities.” 

Chemist Muhammad Alaf showing laboratory equipment at ORA’s New York Medical Products Laboratory
Chemist Muhammad Alaf showing laboratory
equipment at ORA’s New York Medical Products Laboratory

Testing can reveal potential problems

During a previous SLEP testing involving a sterile injection (which is a medicine administered directly into the bloodstream or tissues of the body), staff at NYLMP noticed a troubling inconsistency in appearance across different batches --even within the same batch. Some of the samples they collected showed signs of moisture, which raised red flags for product quality, safety, and effectiveness. 

Using their expertise, training, and keen sense of emergency, staff uncovered atypical results, indicating the presence of unknown impurities. 

Chemist Teneka Jean-Louis using laboratory equipment at ORA’s New York Medical Products Laboratory
Chemist Teneka Jean-Louis using laboratory equipment at ORA’s New York Medical Products Laboratory

“Applying our analytical techniques, we were able to relay this crucial information swiftly to relevant parties,” explains chemist Lieutenant Teneka Jean-Louis. “As a result, the testing protocol for future stockpiled batches was immediately amended to mitigate potential risks associated with these injections. This swift action, directly linked to the initial physical appearance analysis, helped protect the health of public and military consumers, aligning perfectly with the FDA's mission.” 

Automated electronic laboratory reporting systems

Recently, NYLMP launched a pilot program to modernize the SLEP system by automating incoming request instead of using a paper-based system. Through the pilot program, NYLMP aims to streamline information between medical product laboratories and public health agencies. They also plan to foster a more resilient and responsive public health infrastructure and standardize electronic laboratory reporting systems. 

Through its advancing technology, NYLMP has been able to standardize electronic laboratory reporting systems, and software platforms originally designed for scientists to manage and share experimental data within the pharmaceutical industry. 

Now, through the advantages of technology and the pilot program, NYLMP seeks to obtain expedited reporting of critical findings to public health agencies, provide a secure and auditable record of all laboratory findings, and foster collaboration between laboratories; enabling researchers to share data and insights seamlessly. 

Having real-time data exchange allows for quicker identification and response to potential outbreaks, and allows for easier identification of trends and patterns across different facilities,” says chemist David Laguerre.
Chemist David Laguerre looks at samples at ORA’s New York Medical Products Laboratory
Chemist David Laguerre looks at samples at
ORA’s New York Medical Products Laboratory

“Having real-time data exchange allows for quicker identification and response to potential outbreaks, and allows for easier identification of trends and patterns across different facilities,” says chemist David Laguerre. It also minimizes human error and ensures data integrity by providing a complete record of procedures and data - enabling researchers to replicate findings and validate results.” 

The next step of the pilot program is to streamline and harmonize processes and share the results so that other FDA laboratories can use the electronic system within their offices. This isn’t an easy task as quality testing medical products to ensure they are of high quality, safe, effective, and free of contamination and defects takes a keen eye, patience, and expertise. The agency also uses other tools to complement sampling and testing, including inspections, evaluation of post-market quality reports, signal detection, and data analysis to identify products that have potential quality risks.  

Chemist Paula Grier using a laboratory computer at ORA’s New York Medical Products Laboratory
Chemist Paula Grier using a laboratory computer
at ORA’s New York Medical Products Laboratory

“One sample can result in hundreds of pages of data that our agency has to analyze, and our scientists are directly involved in developing and validating reliable laboratory methods to identify impurities and potentially harmful products,” explains chemist Paula Grier. By delivering timely and accurate results, we empower enforcement actions that protect public health and enable timely enforcement actions to safeguard consumers.” 

Additional chemists at the NYLMP include Kenneth Williams and Valentino Fiorella and Program Support Specialist Emma Barton. 

 
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