FDA and Senate Call for Urgent Supply Chain Attention

[originally posted as a blog Sept. 14, 2011]

Today, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy Deborah Autor testified before the US Senate HELP committee regarding the pharmaceutical supply chain and related security issues. She asked for additional FDA authority in several key areas.
These areas include:

• The authority for FDA to promulgate enforceable standards for a national track and trace system. This system should not be able to be pre-empted by state standards, noted Autor. (During the Q&A, GAO, GPhA, and PhRMA representatives said a simple barcode requirement on every product made overseas may be costly and hard to implement and harmonize.)

• The authority for FDA to be able to refuse products from a foreign manufacturer if and when that manufacturer has refused or delayed an inspection (Autor noted that the law is not clear in this area and needs to be clarified. Others suggested sanctions for foreign companies that refuse inspections).

• The authority to issue mandatory recalls of drug products. [The agency has this power for medical devices but has only used the power three times according to Senator Michael Enzi (R-WY)]

• Autor also requested that Congress take action to legally require that drug manufacturers report to FDA drug shortages, contamination, and cargo thefts.
  In general, Autor called for a level playing field for industry. Right now, there are companies who have good quality systems and supply chain tracking and there are companies who do not, she said. The standards need to be raised to require at least a minimum of quality and GMP standards among all manufacturers. In addition, there should be requirements, as there are in other countries, to prove that a product is “good” before it can enter the US market, versus the current requirement that FDA find something “wrong” with a product to deny its entry, she noted.

Senator Barbara Mikulsi (D-MD) in particular stressed the urgency of securing the pharmaceutical supply chain, using the heparin incident as an example. “This issue needs to be elevated to a national security, a homeland security, and a criminal level … so that American people know that if they take [a drug], it will be okay.” Autor agreed with the Senator’s viewpoint.

The hearing was based on the pending PDUFA reauthorization and recent GAO recommendations that FDA be placed on a high-risk watch list of organizations until it more effectively uses its enforceable authorities to make drugs safe for the US market. Senate committee members were concerned about how to handle the fact that 40% of drugs in the US are manufactured outside the country and 80% of APIs are manufactured outside the country, along with growing counterfeits, economically motivated adulteration, cargo thefts, and other supply-chain problems.

Senator Enzi questioned FDA’s response to GAO recommendations to better inspect foreign facilities and to do so with a risk-based approach (i.e., facilities posing greater risks be inspected first). Enzi also questioned why FDA has not updated its API, quality, GMP, and supplier guides for industry to meet current global challenges.

Autor acknowledged the gap between FDA’s statute and the state of global manufacturing. She noted the agency’s efforts to increase information-sharing and training, its harmonization efforts, and its updating of standards. “We’re doing all we can to address GAO’s recommendations,” she said. She pointed to FDA’s Pathway to Global Product Safety and Quality, a new strategy released in June 2011. She also noted partnerships with Europe and Australia as a means to improve the global regulatory landscape by sharing inspection information. FDA cannot do it alone, we need harmonized standards and we need to be able to rely on each other, she said in reference to a global regulatory system.

HELP Committee Chairman Senator Tom Harkin (D-IA) questioned the agency’s limited resources and ability to conduct necessary foreign inspections and the staffing of FDA’s overseas offices such as that in China. He questioned why inspections overseas are preannounced, which Autor explained is necessary because the agency has to get a VISA to enter a country such as China and also must receive a letter of invitation from a country to inspect. This legal situation does not allow for unannounced inspections as we have in the US and needs to be changed, she said.

There was a discussion about whether FDA needs legislation or regulations to improve its enforcement. Autor suggested that if Congress is concerned about these issues that it should take a legislative approach and to make the legislation urgent. Senator Enzi responded by asking for a list of specifics to get Congress going.
Senator Michael Bennet (D-CO) noted that if ever there was a time for a bipartisan approach, this issue of the supply chain is it.
Senator Al Franken (D-MN) asked whether manufacturers should be held accountable for their suppliers and supply chains to take the burden and cost off FDA. Autor said absolutely and that manufacturers are in the best position to do so—they know their products, their risks, and their supply chain players. But it needs to be clear in the law that they are responsible, she added, again calling for Congressional action.

The committee concluded by saying that it will be looing at track and trace sytems, inspection requirements (how often and who), FDA authorities, and more.
Drug shortages, transparency with the public, show factories, and pharmacy burdens were also discussed.

Autor’s full testimony will be posted to the HELP committee website. Other testimonies came from GAO, PhRMA, GPhA, Rx-360, and the PEW Health Group