Nearly a year after the US Food and Drug Administration (FDA) first announced its intent to better secure the pharmaceutical supply chain following a rash of highly publicized counterfeits of Roche's Avastin (bevacizumab) and other drugs in the US, the agency is announcing the launch of a long-planned pilot program intended to assist the agency in going after some of the most difficult-to-track counterfeit products while easing entry standards for trusted products.
The initiative, called the Secure Supply Chain Pilot Program (SSCPP), was first launched in January 2009 with the intent of better securing finished pharmaceutical products and raw ingredients.
As elaborated in a June 2012 Federal Register notice, the program has an end goal of being a proof-of-concept for a larger program to secure the supply chain as part of a risk-based approach, and FDA said it would be opened to an initial pool of 100 applicants.
"Such a program would assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and that may not be compliant," wrote FDA in a statement in 2009. "It will also expedite the entry of products meeting the pilot's criteria into the United States. The pilot was developed with input from U.S. Customs and Border Protection and other stakeholders."
Stakeholders were given the chance to designate up to five product formulations for the pilot program, conditional upon maintaining control over the drug's manufacture and export into the US. While FDA initially said the pilot program would run for just two years, the success of the program has led FDA to seek to continue and improve upon it.
In its 19 June 2012 Federal Register posting, FDA said it was re-submitting the program to the Office of Management and Budget (OMB) for approval, and planned to solicit applications to participate in the program shortly thereafter.
Delays to (Broader) Implementation
The final rollout of the next iteration of the program appears to have taken a great deal longer than anticipated, with FDA only announcing its launch on 19 August 2013, more than a year after it was announced in the Federal Register.
And that delay may be because of Section 713(4)(B)(i) of the Food and Drug Administration Safety and Innovation Act (FDASIA), which FDA noted is "closely related" to the SSCPP.
"Section 713 of FDASIA authorizes FDA to require the submission of drug compliance information as a condition of granting admission to imported drugs, and subsection (4)(B)(i) specifically states that in issuing the implementing regulations FDA 'may, as appropriate, take into account differences among importers and types of imports, and based on the level of risk posed by the imported drug, provide for expedited clearance for those importers that volunteer to participate in partnership programs for highly compliant companies and pass a review of internal controls,'" FDA explained.
The SSCPP will assist the agency in implementing Section 713 of FDASIA, FDA added.
So what is the SSCPP, and what benefits will it provide to participants?
The basic premise, as FDA explains in the latest Federal Register notice, is that certain trusted suppliers will be given expedited access through import controls if they have met various conditions.
As explained in previous notices, potential participants are any companies with a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) approved by the agency. In addition, foreign manufacturers of finished drug products or active pharmaceutical ingredients (APIs) are also eligible for the program. All companies must be in compliance with all FDA regulations, and must have been so for the last three years.
In addition, any participants in the program will need to have a "validated Tier II or Tier III secure supply chain per the Customers and Border Control Customs-C-TPAT Program."
The goal, it seems, is to permit FDA to focus less energy on trusted suppliers-those with high-quality manufacturing operations, strong security controls and trusted supply networks-and free regulators up to focus on those manufacturers with greater inherent risks.
Which is not to say that participants in the SSCPP get a free pass. FDA notes that companies must have a "sufficient plan in place" to recall or correct any products that do not meet current good manufacturing practices (CGMPs) or other standards, and applicants must make all manufacturing records available to FDA "upon request."
Like the original program, FDA estimates the next iteration of the Secure Supply Chain Pilot Program will last for a period of two years and aims to enroll 100 applicants, each with no more than five products per applicant.
Companies wishing to participate should fill out Form FDA 3676. Applications will be accepted on a first-come, first-served basis, and will be evaluated based on several factors, including:
- timeframe for passage through the import and entry process
- level of adherence to program criteria by the applicant
- impact of the SSCPP on the applicant and its drug products.
Federal Register Notice