As more and more risks emerge as a result of a complex global market, industry readies itself for an increase in enforcement from FDA. But it has one request: Play fair.

"As an overarching principle, in order to have that deterrent effect, FDA's actions have to be seen as legitimate," said Dorothy Clarke, Johnson & Johnson's VP of regulatory affairs in the firm's Office of Compliance for Medical Devices and Diagnostics Businesses. "When we believe it's legitimate, we do take it seriously and try to take a lesson from it."

Clarke spoke at the Food and Drug Law Institute/FDA Annual Conference on a panel titled "FDA Enforcement: As It Was and Could Become," where she noted the spike in number of enforcement actions already taken this year.

But it's not the increasing numbers that worry her. "The kinds of things we worry about are arbitrary decisions, unfair or disproportionate enforcement actions, with little opportunity to negotiate," she said.

"At the end of the day we just want to know what the rules are so we can get our products on the market and make sure they are safe," Clarke said, adding, "We also want to see that rule-breakers face the consequences."

"I really think that for industry to have enforcement that we think is fair and well-communicated is really what we need and want," said Clarke.

Despite acknowledging that checks and balances are healthy for industry, especially if the cheaters are caught and all companies are held to the same level of accountability, Clarke was not without reservations: "There is a real risk in the current environment that FDA will become so constrained by safety concerns that industry loses the ability to innovate and patients will suffer."

"Our hope is that we have a risk-based, effective and efficient regulatory system that facilitates timely introduction of new technology while protecting patients and public health."

FDA's Autor: Get Ready Because We're Coming

Hopefully the rest of industry is as ready to face FDA as Clarke seems to be because the Office of Compliance is gearing up for a big year.

"In today's rapidly changing environment, complacency is not an option," said Deborah Autor, director of CDER's compliance office. "I do predict more action. Tell your clients and companies to get going."

The agency has a laundry list of enforcement tools, including seizures, injunctions, import detentions, withdrawal of approvals, recalls, civil money penalties, debarments, misdemeanor criminal prosecutions, felony prosecutions, criminal fines and imprisonment, and inspections, to name just a few.

And with an ever-evolving global market, it is poised to use them all.

Civil money penalties is the agency's newest tool, which gives it authority to seek penalties as high as $10 million, depending on circumstances. "[This authority] reinforced the agency's position that sponsors bear clear responsibility to ensure patient safety," said Autor.

"I believe FDA's civil enforcement was cuffed and starved," said Robert Spiller, a former FDA attorney who retired in 2003 but still does training and consulting for the agency. Spiller argued that enforcement was impeded by many obstacles that reduced its ability to bring in enforcement cases. "Now it's a new day. This congress and administration seem to be providing the climate and resources."

Supply Chain Challenges

Incomplete information about supply chains coupled with a very complex system of foreign, federal and state agencies is a particular challenge in the globalizing market, said David Horowitz, assistant commissioner of Policy at FDA's Office of Policy and Planning.

"We don't have all the regulatory standards that are needed and the clarity to achieve maximum corporate accountability and responsibility," he said. "Supply chain safety is really about both regulators and the regulated working together to address these challenges."

With more foreign facilities supplying the U.S. each month, coupled with the increasing volume of import and outsourcing of clinical trials, the complexity of the supply chain continues to grow.

"What we all realize is the reality of the challenges of globalization, which has fundamentally changed the environment for regulating food and drugs in our country," said Murray Lumpkin, deputy commissioner for FDA's International Programs.

"Most importantly, the imports are coming from countries with less well-developed regulatory systems," Lumpkin said. "We don't have local supermarkets in the U.S., we have global supermarkets."

Guidances and Pilot Programs

In an attempt to begin addressing these issues, FDA initiated a number of pilots and guidances. One such guidance, Good Importer Practices, will create a product safety manual to be used by a whole host of federal agencies, including the Department of Commerce, USDA, HHS and EPA, to name a few. Establishing an umbrella document will ensure that agencies uphold a shared set of common principles.

Also in the works is a Secure Supply Chain pilot program, which will allow parties to benefit from the possibility of getting their goods through the system faster in return for a greater assurance that the products coming in have secure supply chains. This will allow FDA to implement a more risk-based approach for places where it has greater concern.

A third-party certification plan is another idea the agency is mulling over. While this would mainly apply to food and feed, Horowitz said its concepts should be applied more generally to include pharmaceuticals as well. It would provide opportunities for firms who are doing the right thing to demonstrate that to FDA so as not to waste its time. Incentives include firms getting expedited treatment at the border, and reduced rates of examination and sampling. In some cases an import alert could even be deemed not to apply.

"I believe these third-party sources of information are very critical to the paradigm shift, but they will supplement FDA, not substitute FDA's role," said Horowitz.

Finally, FDA is drafting a private labs guidance to ensure lab test results are of adequate quality. This would require companies to submit test results that the products are in compliance and create incentives for importers to use accredited labs. In exchange for doing that as well as providing advanced notice to FDA that the results are coming, companies would receive abbreviated processing.

"We have to develop systems that will give us the comfort level we need," said Horowitz. "In order to be successful, FDA must have the infrastructure in place to oversee and evaluate. That's not something we have in place right now."

Words Of Wisdom For Industry: Be Proactive

Autor came to the meeting with advice for industry: Be proactive.

"You can wait for me to take action, but I would say don't wait," she said. "Every drug without FDA approval is subject to action. All of them are priorities. We will not tell you what is next."

She stressed that companies must be conscious of product vulnerabilities, and always on the lookout for red flags. Economic incentives and lax oversight, for example, promote risky criminal behavior. "Companies must strictly adhere to legal requirements designed to protect product quality and integrity," she said, adding that "All parties involved in the drug lifecycle must recognize that they have an ethical liability."

Due diligence needs to be applied no matter what, she said, and that includes when a company has acquired a product. "You have to be responsible for ensuring the ingredients you get are not misbranded. If you are outsourcing, you are responsible."

Lumpkin piggy-backed on the need to be proactive. "We cannot continue to use the 20-century paradigm, where we stand out at the border and keep things out," he said. "We need to go where they have been manufactured so when they get to the border, we're not trying to audit bad products out, we're trying to allow good products in."

- Lauren Smith (lauren.smith@elsevier.com)

FDA Ups The Ante In Enforcement; Industry Wants Fair Play

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