FDA Developing Global Action Plans for Safety of Food and Drugs

(With enactment of the Food Safety Modernization Act (FSMA) in 2011, Congress provided FDA with critical authorities to ensure the safety of both domestic and imported food. With regard to imported food, the FSMA provides FDA with tools² both at the border and further up the supply chain. The law also charges FDA with helping to build capacity for food safety in other countries that export to the U.S. and with working closely with foreign governments to enhance food safety.)

FDA Needs to Partner w/Food & Medical Industry to Push Safety up Supply Chain

Commissioner Hamburg stated that the risk to the U.S. food and medical products supply comes from sources around the world, and that FDA is able to more easily address the threat posed by domestic suppliers through the inspection of facilities and other means. However, because FDA does not have the same level of resources on the ground, it is often difficult for FDA to obtain the same level of confidence with regard to the safety of food and drugs produced abroad.

FDA must partner with other federal, state, local and international regulatory and law enforcement agencies and industry to push responsibility for safety and quality further up the supply chain.

FDA Is Developing Global Strategy/Action Plan to Oversee Product Safety

The Commissioner stated that FDA is developing a global strategy and action plan that will allow FDA to more effectively oversee the safety of all products that reach U.S. consumers in the future. As part of the strategy, FDA will:

• work to build a global data-information system and network and proactively share data with partners;
• build additional capabilities in intelligence gathering with an increased focus on risk analytics and a transformed IT capability;
• leverage the efforts of public and private sector third parties and industry and will effectively allocate FDA resources based on risk;
• strengthen FDA's ability to perform targeted inspections at the border, in concert with Customs and Border Protection (CBP); and
• partner with foreign counterparts to create a global coalition of regulators focused on ensuring and improving global product safety:

1. FDA now has permanent FDA overseas posts that enable FDA to have a regional presence around the world, and which serve as important hubs for improved coordination with regulatory authorities in other nations and industry. They also conduct and facilitate inspections and other on-the-ground activities in foreign sites. FDA has offices in China (Beijing, Shanghai, Guangzhou,); India (New Delhi, Mumbai); Mexico (San Jose, Costa Rica; Mexico City); and Chile (Santiago). FDA will soon have a post in Amman, Jordan and a post in Pretoria, South Africa.

2. FDA has more than 30 additional agreements with foreign counterpart agencies to share inspection reports and other non-public information that can help FDA make better decisions about the safety of foreign products.

3. FDA is also engaging in bilateral and multilateral international standards development and harmonization efforts.

New Drug Integrity & Security Program Launched to Secure Drug Supply Chain

To further secure the drug supply chain, Commissioner Hamburg stated that FDA has started a new Drug Integrity and Security Program, which focuses on drug quality issues such as counterfeiting, economically motivated adulteration, cargo theft, and other supply chain threats and vulnerabilities.

The program was recently launched and is currently establishing its strategic plan, which may include industry guidance, regulation, inspections, collaboration, outreach, enforcement strategies, and other measures.

FDA Could Benefit from New Legislative Authorities to Hold Industry Accountable

According to FDA, it could benefit from new legislative authorities that are, at a minimum, commensurate with those of its global counterparts. New regulatory authorities that may help ensure that FDA can hold industry accountable for the security and integrity of their supply chains and the quality control systems they use to produce drugs for the U.S., such as the following authorities to:

• Address threats wherever they arise- while FDA does not seek to interfere with regulatory authorities outside the U.S., having express authority to address threats to U.S. consumers, wherever they may arise, is critical.
• Refusal of admission if inspection is delayed, limited, or denied- the authority to provide a strong incentive for foreign firms to allow FDA to perform inspections, and to permit FDA to exclude from domestic commerce products whose foreign manufacturers are not willing to subject themselves to the same requirements as domestic manufacturers.
• Mandatory recall authority-- under current authority, FDA lacks the authority to compel industry recalls for products it believes that pose a risk, leaving the public exposed to potentially serious health risks. FDA currently has this authority for medical devices, infant formula, and now food, but not for drugs.
• Administrative detention and destruction- FDA is often forced to return violative products to their sender, which can then find their way back to U.S. ports of entry several times, wasting critical resources that could be better spent identifying new threats. This authority would level the playing field for those who produce compliant products, whether in the U.S. or abroad.
• Enhanced criminal and civil penalties for foreign and domestic suppliers- statutory changes could help to flip the cost-benefit ratio against counterfeiting pharmaceuticals, deter would-be criminals from targeting this area, and bring FDA’s penalties in line with those for other serious federal health and safety violations.

(Note that on April 12, 2011, Representative Dingell (D) introduced H.R. 1483, the Drug Safety Enhancement Act, which he states would equip the FDA with the authorities and resources it needs to adequately regulate the growing global marketplace for pharmaceuticals. According to Representative Dingell, the Drug Safety Enhancement Act would, among other things:

• Prohibit entry of drugs coming from domestic and foreign facilities that limit, delay or deny FDA inspections;
• Prohibit the entry of drugs into the U.S. lacking documentation of safety;
• Provide strong new enforcement tools, including mandatory recall authority, increased civil and criminal penalties, and new FDA authority to subpoena records related to possible violations)

¹Subcommittee on Oversight and Investigations, House Committee on Energy and Commerce.

²For example, the FSMA requires importers to perform risk-based verification activities of their foreign suppliers to ensure that the food is safe. The FSMA also provides an incentive for importers to take additional food safety measures by directing FDA to establish a voluntary program through which imported food shipments may receive expedited review if the importer has taken certain measures to ensure the safety of the food. Last year, FDA conducted more foreign inspections than ever before in its history and is on track to surpass that record again this year.

(See ITT's Online Archives or 04/15/11 news, 11041502, for BP summary of Commissioner Hamburg discussing FDA's PREDICT to screen imports of food and medical devises also from this testimony.

(See ITT's Online Archives or 04/14/11 news, 11041417, for BP summary of the new FDA Drug Safety bill introduced in the House.)