FDA Program to Loosen Import Restrictions for 13 Major Pharmaceutical Manufacturers

Posted 19 February 2014 | By Alexander GaffneyRAC

Thirteen of the US' most prominent pharmaceutical manufacturers will be allowed to import their products into the US with less regulatory scrutiny under a pilot program set to begin this year, the US Food and Drug Administration (FDA) has announced.

Background

FDA first announced the pilot program, known as the Secure Supply Chain Pilot Program (SSCPP) in January 2009 with that stated intent of better securing finished pharmaceutical products and their raw active ingredients.

So what is the SSCPP, and what benefits will it provide to participants?

The basic premise, as FDA explained in a 2013 Federal Register notice, is that certain trusted suppliers will be given expedited access through import controls if they have met various conditions. FDA wants the program to be a proof-of-concept for a larger program to secure the supply chain as part of a risk-based approach.

As such, participants in the program are supposed to be the best of the best-those manufacturers that FDA trusts most and finds the least problems with. But more specifically, participants in the SSCPP are any companies with a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) approved by FDA. Foreign and domestic drugmakers alike are eligible for the program, but 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 Custome and Border Control Customs-C-TPAT Program," according to FDA.

What's the End Goal?

SSCPP's goal 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.

"By creating incentives for manufacturers to adopt best practices for supply chain integrity, we can enhance the quality and safety of imported drugs," said Carol Bennett, acting director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, in a February 2014 statement.  "The program also allows the FDA to focus resources on the areas with the greatest potential risk to consumers."  

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."

Thirteen Companies

The program has already undergone a limited rollout, and last year FDA said it planned a phase-up program set to include as many as 100 applicants, each with no more than five products per company.

Now FDA has unveiled the opening list of companies enrolled to participate in that second two-year phase, representing some of the most prominent companies in the US and around the world.

Companies participating in the pilot are:

  • AbbVie Inc. 
  • Allergan, Inc.
  • Astellas U.S. Technologies, Inc.
  • Bristol-Myers Squibb Company
  • Celgene Corporation 
  • GE Healthcare Inc.
  • GlaxoSmithKline LLC
  • Merck Sharp & Dohme Corporation 
  • Mylan Pharmaceuticals Inc.
  • Novartis Pharmaceuticals Corporation 
  • Pfizer, Inc.
  • Teva Pharmaceuticals USA, Inc.
  • Watson Laboratories, Inc.

These companies are those which have fulfilled "participation conditions," including those conditions noted earlier (regulatory compliance, C-TPAT program, etc) as well as having deficiency correction and recall initiation plans in place. In addition, companies will need to maintain full control over products from the time of manufacture until the time a product is imported into the US.

Based on the program's success, a "more permanent program may be established and possibly extended to additional participating companies," FDA said.

 

FDA Statement

Prior Focus Reporting


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe