FDA Starting to Implement Drug Supply Chain Provisions of 2012 Law
Implementation of supply chain provisions of the “historic” and “timely” Food and Drug Administration Safety and Innovation Act of 2012 has begun in earnest, said FDA Commissioner Margaret Hamburg at a July 12 public meeting. Not only did the law reauthorize and create new user fee programs that came at a “critical moment” because of budget constraints, but Title VII of FDASIA provided FDA “with the new authorities needed to better oversee our drug supply chain, a chain that is progressively more complex and more global,” she said. Publication of a proposal on administrative detention of drugs, set for July 15, marks one of the first steps towards putting Title VII in place (see 13071211). But implementation will be long and arduous, said another official at the meeting.
Sign up for a free preview to unlock the rest of this article
If your job depends on informed compliance, you need International Trade Today. Delivered every business day and available any time online, only International Trade Today helps you stay current on the increasingly complex international trade regulatory environment.
The need for the changes brought about by FDASIA result from a dramatic shift towards a globalized drug market. Almost 40 percent of drugs taken in the U.S. are made elsewhere, and 80% of the active pharmaceutical ingredients used to make those drugs come from abroad, she said. “We now receive imports from more than 150 countries, many of them with much less sophisticated manufacturing and regulatory oversight systems than our own,” said Hamburg. The supply chain itself has grown more complex, with an increasing variety of sources, shippers, and methods of transportation. “There is no sign this trend is going to abate,” said Hamburg, noting that drug imports have quadrupled over the past decade.
Because of the globalization of the drug industry, FDA saw it had to make a “transformative change … from a domestic agency that’s working in the international arena to an agency that’s truly globally focused and one that can adequately conduct its business in a changing global environment,” said John Taylor, acting deputy commissioner-Global Regulatory Operations and Policy, echoing Hamburg’s remarks. “The border can no longer be the primary line of defense.”
“That’s why this new legislation is so very important and so timely,” said Hamburg. “Thanks to title VII of FDASIA, FDA now has a variety of new tools to help secure the safety and integrity of drug ingredients and finished drugs that are produced overseas and shipped across our borders for use by patients and professionals in the United States.
FDA is now beginning to implement Title VII, Hamburg said. FDA won higher penalties for counterfeiting drugs from the Federal Sentencing Commission earlier in 2013. And in the July 15 Federal Register, FDA is proposing new regulations on administrative detention of drugs. “These are the first of several provisions we’re implementing under Title VII, pursuant to our authority under this new law.
Implementation Will be Tough; Immediate Impact an Agency Priority
But implementation won’t be easy, said Susan de Mars, senior advisor-Global Regulatory Operations and Policy at FDA. “While these are all very important and valuable authorities, they also carry with them a very heavy workload in terms of what it takes to actually put them in place,” she said, referring to a long list of necessary rule changes. “Beyond that, there are also the many significant operational changes that need to be put in place to fully implement Title VII,” she said. For example, FDA will need create and improve databases to be able to use the enhanced information Title VII’s provisions allow it to collect. It also needs to change its policies and procedures. FDA’s strategy will be “trying to prioritize based on where we can achieve immediate impact.
One such regulation would implement use of the unique facility identifier (UFI) for the purposes of Section 701 and 702 domestic and foreign establishment annual registrations. The registration requirement gives FDA a way to identify the existence and location of facilities, which can be difficult for overseas operations, de Mars said. “We consider this a priority in terms of the implementation of Title VII” she said, partly because the UFI is a “foundational piece” used for the purposes of other provisions as well. She said FDA hopes to have a rule that specifies how to use UFIs “very soon.”