Problems in Sharing Drug Inspections with EU
Attorney Mark Schwartz (Hyman, Phelps & McNamara) says that FDA has been working for more than a decade to reach an agreement with the European Union that would allow for regulatory bodies to avoid duplication of their surveillance activities and lower the overall costs of their respective programs. Writing in his firm’s FDA Law Blog, Schwartz says that according to agency associate commissioner for global regulatory policy Dara Corrigan, 43% of FDA inspections are in EU countries, meaning there could be significant opportunities for savings. Corrigan reportedly has said that $18.5 million in inspection costs could be used elsewhere if FDA did not inspect facilities in the EU. “And these costs are only going to increase as the number of domestic inspections over the past several years has gone down while the number of foreign inspections has increased commensurately,” Schwartz writes. “That trend is expected to continue.”
He says that historically one of the main stumbling blocks to an agreement has been the disparate regulatory structures between the U.S. and the EU since there have been 28 member states in the EU and most, if not all, have their own medicines authorities in addition to the European Medicines Agency (EMA). “This web of overlapping state and super-state drug authorities has made it difficult for FDA to reach agreement with the EU,” Shwartz says.
Another stumbling block has been the sharing of trade secret information between FDA and the EMA. While the EMA has been sending unredacted summaries of EU inspections to FDA for some time, he writes, FDA’s reports to the EMA have been redacted because by law it is only allowed to share trade secret information with a foreign government if the FDA commissioner certifies that the foreign government has the ability to protect the information from disclosure.
Corrigan indicated that FDA expects to make a decision this year on whether an EU member state is capable of performing drug facility inspections to the agency’s satisfaction, and whether the agency can confidently rely on those findings.
Schwartz says that the notion of having a foreign inspectorate perform drug inspections on FDA’s behalf is problematic given that inspections by FDA investigators are already very inconsistent. He says that agency representatives have long acknowledged that the agency doesn’t have an objective method for measuring quality in the drug industry (such as the facilities in which cGMPs are improving and by how much and in what way). There also is no reliable method for making cGMP comparisons between facilities manufacturing similar products, or for comparing the results from within a facility over multiple inspections.
“It would seem that rectifying these significant lacunae in FDA’s inspectional responsibilities should be the first order of business for the agency,” Schwartz concludes, “prior to even considering delegating the responsibility for EU inspections to a foreign inspectorate which is not schooled in FDA’s precise cGMP requirements.”