FDA Adapts Enforcement Strategy In Increasingly Globalized Market
This article was originally published in The Rose Sheet
Executive Summary
FDA will overhaul its enforcement approach to reflect the impact of globalization by partnering more with foreign counterparts, streamlining inspections, recalls and emergency responses and using stiff criminal sanctions to deter noncompliance, FDA officials say.
FDA will expand enforcement beyond U.S. borders in 2012 to address developing safety threats from increasing globalization, top agency officials say.
“We have to shift to a more global agenda” that addresses the emerging regulatory environment in which national borders are less relevant to product safety than in the past, said Howard Sklamberg, deputy associate commissioner for regulatory affairs at FDA’s Office of Regulatory Affairs.
At the Food and Drug Law Institute’s Enforcement, Litigation and Compliance Conference Dec. 6 in Washington, D.C., he explained that FDA will overhaul its enforcement approach to reflect the impact of globalization by partnering more with foreign counterparts, streamlining inspections, recalls and emergency responses and using stiff criminal sanctions to deter noncompliance.
FDA will streamline and conduct more inspections to address the enormous challenges posed by the rapidly growing volume of regulated imports and the increasing complexity of the global supply chain, Sklamberg said.
The exec predicted imports will continue to increase 5% to 15% through 2015 – nearly tripling the number of FDA-regulated products imported since 2007.
FDA stepped up its scrutiny of imported cosmetics over the summer, with cosmetic import refusals rising 67% in June, July and August from the same period in 2010 (Also see "FDA Cosmetic Imports “Enforcement Spike” Serves To Warn Multinationals" - HBW Insight, 17 Oct, 2011.). The top reason for refusal was unapproved color additives.
FDA will increase foreign inspections in response to the growing number of manufacturers abroad, Sklamberg said. He noted that the agency already increased foreign food facility inspections from 354 in fiscal 2010 to 637 in fiscal 2011, with more in the pipeline.
However, the demand to conduct more foreign inspections – a total of 19,200 in the next five years – could outpace FDA’s budget and resources, Sklamberg cautioned.
“We are trying to do a lot more … with not many more resources,” he said, adding that one way FDA is inspecting “smarter” is through partnerships with its international counterparts.
“We can’t be everywhere, so we have to look at how we can move towards relying on our international partners and regulators,” Ilisa Bernstein, acting director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research, said at the conference. She noted FDA is conducting pilot programs and some joint inspections “particularly with Australia, Europe and Canada.”
Globalization Increases Supply-Chain Threats
Globalization also threatens food and drug safety by creating more links in the supply chain that are vulnerable to threats of counterfeit, diversion and cargo theft. Addressing these risks is another FDA enforcement priority, Sklamberg said (Also see "Threat Of Adulteration For Profit Grows With Globalization Of Supply Chain" - Pink Sheet, 13 Oct, 2008.).
Bernstein said the office is developing standards for tracking and tracing drug packages through the supply chain and is “hoping to issue something in the near future.”
As with the inspections, the office is teaming with international partners to block diversion and counterfeiting. For example, it participated in Operation Pangea IV with 81 other countries which targeted 997 websites illegally selling unapproved or misbranded drugs to U.S. consumers. The operation was part of the International Internet Week of Action and resulted in warning letters going to more than 700 websites and the suspension of nearly 600 sites.
FDA also is looking for ways to more quickly and efficiently remove not only intentionally compromised products from the market, but also products that are unintentionally compromised through the manufacturing, packaging or other points in the process.
“We will comprehensively look at our recall process to see are there things we can do in it that are simply more efficient,” Sklamberg said. “Are there better ways we can communicate with the pubic so the public can know more quickly what the status is of a recall, and ways we can work more efficiently with a firm that is doing a recall in terms of audit checks and other parts of the recall?”
FDA Enforcement For Deterrence
FDA plans to clarify concerns in warning letters and add more teeth to the process in 2012, Sklamberg said.
He recognized that warning letters do not have the force of law, but urged firms to address problems in the letters in a timely fashion, or the agency will take enforcement action. To improve compliance with letters, the agency plans to conduct follow-up inspections and work “with firms in the warning-letter process in a way that firms can understand what FDA wants,” he said.
He also reminded industry that FDA no longer issues repeat warning letters. So if a firm adequately addresses a problem in a warning letter, but it occurs again, the agency could take enforcement action.
Moreover, FDA will not hesitate to make examples out of firms and individuals involved in serious criminal situations, Sklamberg said.
“When we have an issue with a firm or generally a public health issue, what we want is not to just deal with this situation immediately, but make sure it doesn’t happen again,” according to the exec.
Finally, FDA plans to take enforcement action more quickly by streamlining its review process, he said.