Trade and Pharma Groups Urge Caution as FDA Moves Toward New Drug Import Requirements

Pharmaceutical and trade groups urged FDA to tread lightly as it puts in place new requirements for drug importers under the Food and Drug Administration Safety and Innovation Act (FDASIA). The National Customs Brokers and Forwarders Association of America (NCBFAA), American Association of Exporters and Importers (AAEI), and the Pharmaceutical Research and Manufacturers of America (PhRMA) each submitted comments in favor of an FDA definition of importer that recognizes that trade services firms like customs brokers can’t be responsible for compliance. They also said FDA should be careful not to impose new data submission requirements that are too onerous. AAEI and PhRMA pushed FDA to establish a trusted drug importer program based on the Customs-Trade Partnership Against Terrorism (C-TPAT), and NCBFAA cautioned against a repeat of the U.S. agent dilemma caused by FDA’s foreign food facility registration requirements.

FDASIA, which was signed into law in 2012, requires that importers of drug products register with FDA and submit additional information to the agency, among other things. NCBFAA, AAEI, and PhRMA submitted comments (here) in connection with a July meeting on the new requirements (see 13071224).

Importer of Record Definition

Worried about the potential for customs brokers to be considered the importer of drug products for FDA compliance purposes, NCBFAA said the agency should define the term “importer” in FDASIA to be the “person who caused the drug product to be imported.” Under NCBFAA’s proposed definition, the importer would normally be the U.S. owner of the product, or the U.S. purchaser or consignee, it said. That person has a financial interest in the drugs and is the most likely to have knowledge and control of the product’s supply chain, NCBFAA said. And that’s important if the importer has to provide compliance information to FDA, as required by FDASIA, the trade group said. The customs broker, on the other hand, usually doesn’t see the merchandise and has to rely on the representations of their clients, said NCBFAA.

Although they didn’t put forward the same proposed definition, AAEI and PhRMA also recognized the difficulty third-party importers of record will face if FDA defines “importer” as the CBP “importer of record.” Each group proposed to define importer as the entity responsible for compliance with FDA regulations. ”This definition would distinguish between those entities that take possession or title to a drug (the importers) and those entities that merely handle or act as carriers or facilitators for the import of the drug,” said PhRMA. That would be consistent with FDA definitions for importers of food and devices, the pharmaceutical group said. Both AAEI and PhRMA said the importer should be able to designate the importer of record to provide required information on drug imports, if the importer and importer of record aren’t the same entity.

Information Required Upon Importation

Commenters also cautioned FDA against requiring too much information from drug importers. NCBFAA urged the agency “to be selective in deciding what information must be submitted, when it must be submitted and by what means.” Any documents required at time of entry would have to be submitted electronically, whether directly to CBP or via a web posting, which will cause programming headaches for the government and private sector. So FDA needs to coordinate with CBP to make sure any required data can be handled through the Automated Commercial Environment (ACE) and the International Trade Data System (ITDS), NCBFAA said. The trade group also said FDA should avoid requiring “repetitive or redundant” information for each entry where such data is available to FDA elsewhere. “The point is, the data transmission requirements at entry should not become so onerous that they cannot reasonably be met,” NCBFAA said. “Overwhelming the entry process will not lead to a safer drug supply chain.”

AAEI echoed NCBFAA’s concerns about redundant information requirements. “Since FDA has a lot of information on the imported products through the pre-market regulatory process, we suggest FDA require specific and limited information that indicate the risk posed by the product (e.g., manufacturer, facility, country of origin) and confirm that the product complies with the applicable law,” AAEI said. Other information could be required when a product is registered with FDA, it said.

Both AAEI and PhRMA said FDA should vary its information submission requirements based on the risk of the importer. PhRMA said FDA should “distinguish between the following three categories of importers: trusted importers (who should be participants in FDA’s trusted importer program), unknown importers, and high-risk importers.” The information required from each type of importer should depend on the “track record and trustworthiness of the importer,” the pharmaceutical group said.

Trusted Drug Importer Program

Commenters heavily favored the establishment of an FDA trusted drug importer program that would be similar to CBP’s Customs-Trade Partnership Against Terrorism (C-TPAT). Drug importers would respond by improving their compliance regimes, investing more resources to ensure product safety and protect their brand, AAEI said. But FDA should learn about the latest industry supply chain security standards before it implements such a program, the association said. “Many of these programs are at the cutting edge of supply chain security and FDA should first learn what already exists before establishing any program standards.

PhRMA said any trusted drug importer program should be aligned with C-TPAT, either by requiring Tier II or III participation in the CBP program, or by putting in place standards that are similar to CBP’s. If an importer is accepted into FDA’s trusted drug importer program because it has a strong compliance history and appropriate internal controls for the drug it imports, “the importer should be exempt from additional inspections or screening at the border unless FDA has specific intelligence about a potential threat,” PhRMA said.

Both PhRMA and AAEI said FDA should implement the trusted drug importer program by assigning trusted traders new Affirmation of Compliance (AoC) codes that denote trusted status.

Foreign Drug Supplier Registration

Finally, smarting from its experience with foreign food facility registration and U.S. agent requirements, NCBFAA said FDA should make sure a notification system is in place to make sure a U.S. agent knows it is being designated. “In the food facility registration, this has been a problem, where U.S. entities are designated as U.S. agents, but either do not know they were so designated and/or do not wish to be an agent,” NCBFAA said. “We recommend that the FDA require an affirmative statement of registration signed by both parties be submitted or establish a similar transparent process whereby the agent explicitly accepts this specific role for the purpose of drug product importations,” the trade group said.