PHARMACY

FDA grants pharmacies more time for Track & Trace requirement

BY Antoinette Alexander

WASHINGTON — The Food and Drug Administration on Tuesday issued guidance indicating that the agency would give pharmacies until Nov. 1, 2015 — an additional four months — to comply with product tracing requirements scheduled to take effect July 1, 2015.

The FDA will not take enforcement action against a pharmacy that receives any drug product without also receiving the tracing information until Nov. 1, 2015. However, as of July 1, pharmacies are responsible for transmitting tracing documentation to purchasers of their drugs, when required to do so under the DSCSA. Starting Nov. 1, 2015, pharmacies will have to comply with the full scope of the DSCSA dispenser tracing requirements.

Commenting on the news, National Community Pharmacists Association CEO B. Douglas Hoey issued a statement that read: “Pharmacists appreciate and support the FDA’s decision announced today, which will help protect patients from disruptions in access to prescription drugs that may have otherwise and inadvertently occurred. Due to circumstances beyond their control, many pharmacies would have had difficulty complying with the July 1 statutory deadline. The FDA’s latitude should hopefully allow pharmacies to continue to work with their wholesaler partners in order to achieve compliance with new product tracing requirements intended to enhance the safety of the U.S. pharmaceutical system.”

On Nov. 27, 2013, the President signed the Drug Supply Chain Security Act into law, which helps ensure that the drug supply chain is secure from the point of manufacture through to the point at which pharmacies dispense those drugs to their patients. Implementation of the law has been ongoing over the past year and half. Starting July 1, 2015, pharmacies were to be required to only accept drugs that were shipped with corresponding tracing documentation.

While National Association of Chain Drug Store members worked hard to achieve DSCSA compliance by July 1, NACDS stated that it requested enforcement discretion from the FDA on two drug product categories — 340B drugs and drop shipment drugs — to help ensure that patients were not delayed in receiving their much-needed medications.

Because of the structure of the 340B program, in many instances a wholesaler will send the 340B drug to the pharmacy and send the tracing documentation to the health care entity. This undermines the intent of the DSCSA to require both the drug product and the tracing documentation to flow together through the supply chain, NACDS stated.

While the manufacturers of drop shipment drugs are able to send the tracing data directly to the pharmacies, progress has been slow in developing an electronic method for transmitting that tracing data, NACDS stated. Electronic transmission is critical for pharmacies because the DSCSA requires pharmacies to have such data readily available in case the FDA needs to investigate possibly illegitimate drug products.

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IGPA calls for TPP focus on generics

BY David Salazar

WASHINGTON — The International Generic Pharmaceutical Alliance has issued a statement calling on parties negotiating the Trans-Pacific Partnership to make access to affordable medication a priority.

According to IGPA, TPP, which is being negotiated by 12 countries including the U.S., in its current state “protects the interests of brand medicine manufacturers at the expense of public health.”

“IGPA supports trade agreements which promote the distribution of safe and affordable medicines and contribute to the sustainability of healthcare systems globally,” IGPA said. “Unfortunately, based on available information, TPP will threaten the right of “access to medicines for all” enshrined in the 2001 WTO Doha Declaration and recognized by all 12 TPP countries.”

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Access barrier created by distinguishable names for biosimilars, GPhA says

BY Michael Johnsen

WASHINGTON — The Biosimilars Council, a division of the Generic Pharmaceutical Association, on Tuesday strongly urged the Department of Health and Human Services and the Food and Drug Administration to avoid any departure from the currently accepted international nonproprietary naming system. In a letter sent today to HHS and FDA, the Biosimilars Council joined a group of healthcare stakeholders to raise shared concerns that adopting distinguishable names for biosimilars and biologics would erect barriers to patient access to new, more affordable medicines and could jeopardize their safety.
 
“Organizations representing the nation’s pharmacies, pharmacists, insurers, state employee retirement systems, taxpayers and others agree that biologics and biosimilars should share the same name in order to ensure patient safety and avoid confusion among providers and dispensers,” stated Ralph Neas, president and CEO, GPhA.
 
“We share the FDA's deep commitment to patient safety, and as such, we believe that biologics and biosimilars should be required to have the same International Nonproprietary Name," the Council submitted in its letter. "Requiring different INNs for biologics and biosimilars could lead to patient and prescriber confusion, increasing the possibility of medication errors, and would also effectively separate the biosimilar from existing safety information about the underlying molecule.”
 
The Council suggested that the current mechanisms in place (e.g., NDC code, lot number, brand name, manufacturer, etc.) are more than sufficient to allow for the tracking of important safety information related to new biosimilar products. 
 
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