FDA's emphasis on follow-through in its revamped enforcement strategy may help weed out bad actors from legitimate industry.

To more effectively protect the public health, FDA will implement a six-step plan to improve enforcement, Commissioner Margaret Hamburg said at an Aug. 6 Food and Drug Law Institute event in Washington.

The former New York City health commissioner said FDA will increase the efficiency of its enforcement actions by expediting its warning letter process, setting post-inspection deadlines for firms to comply with and prioritizing "follow-up on warning letters and other enforcement actions."

Food and drug attorney Marc Ullman applauded the announcement, saying the supplement industry historically has not taken warning letters seriously because of the lack of consistent follow-up by FDA.

The perception is "there has not been a great risk associated with receiving a warning letter," Ullman said in an interview. "To the extent that it's necessary for any regulatory scheme to have a deterrent effect in order to be effective, real follow-up and additional enforcement action coming on the heels of warning letters is necessary and that has kind of been lacking at FDA."

Ullman noted FDA likely will generate more warning letters, but he believes they will focus only on more serious violations.

Ullman, of New York-based Ullman, Shapiro & Ullman, said, "I see a lot of good things here as long as the actions are implemented with a sensible set of priorities in an evenhanded manner."

Built For Speed

Hamburg said over the past several years, agency actions "have been hampered by unreasonable delays" and some "serious violations have gone unaddressed for far too long."

The agency also is setting a firm 15-day post-inspection deadline for companies to respond to FDA's inspection reports, after which FDA will take appropriate action, including issuing a warning.

"Frankly, I can see in some past responses where there's a lot of back and forth and stall and delay and let's wait and see what the company does," she said. "Some of these timeframes just don't seem acceptable to me."

She said FDA also will speed up the process by allowing the majority of letters to bypass clearance by the Office of Chief Counsel, which will only review letters "that present significant legal issues."

OCC will continue to review letters that are "novel, complex and significant," which would be determined by experts at the agency, FDA Assistant Commissioner for Policy David Horowitz noted.

The Close-Out

To mark warning letter compliance, FDA will implement a "close-out" process that publicly indicates when a firm has addressed its concerns.

Once FDA determines that a company has fully corrected violations raised in the warning letter - usually based on a follow-up inspection - it will send a close-out letter to the company and post the information on its Web site.

Hamburg said close-out letters will give firms incentive to comply.

"I hope that receiving a close-out letter quickly becomes the top industry priority," Hamburg said at the FDLI meeting, billing it as "an effort to work with industry to support and foster a rapid recovery when they've done the right thing."

FDA hopes to begin the process with letters issued from Sept. 1 onward.

Ullman said the close-out communication "is something that has been noticeably missing. I think the commissioner is dead-on when she says that this would be a motivator for companies to do so."

"It is important especially in a situation where FDA is willing to acknowledge that the response to the warning letter is appropriate and has explained why there is no violation that the agency be prepared to acknowledge that," he said.

Beyond Warnings

The agency will no longer issue multiple warning letters to noncompliant firms before taking more significant enforcement actions, Hamburg said.

In some cases, FDA may move immediately, without issuing a formal warning letter, on "significant health concerns or egregious violations" that pose "an immediate threat to health" and when informing the public and removing a product from the market is necessary to prevent harm, she said.

The agency already has acted swiftly in getting potentially unsafe products off the market under its new leadership. For example, it issued Zicam manufacturer Matrixx Initiatives a warning letter for its intranasal zinc-containing OTC cold remedy products while simultaneously alerting consumers (¹ Also see "FDA Uses "Unusual" Action To Get Matrixx's Zicam Off The Market" - Pink Sheet, 29 June, 2009.).

More recently, FDA seized Clarcon Biological Chemical Laboratory's potentially contaminated hand sanitizer products because the firm did not agree to immediately destroy products it recalled (see story p. 9).

The agency also is working more closely with regulatory partners at the state, local and international levels.

Hamburg discussed FDA's success in enforcement actions against the marketing of fraudulent products to treat or prevent H1N1 influenza, as well as metabolic steroids masquerading as dietary supplements (² 'The Tan Sheet' April 3, 2009 and ³ Also see "FDA Gives Firms Hawking H1N1 Remedies Tighter Deadline To Comply" - Pink Sheet, 25 May, 2009.).

Ullman said Hamburg's mention of these products showed her making a "hugely important distinction" between legal and illegal products.

Seeking "More Effective Tools" From Congress

FDA does not need new legislation to implement the new enforcement initiatives, Hamburg noted, but she said the agency will "seek more effective tools" from Congress.

Hamburg applauded the House's passage of the Food Safety Enhancement Act, citing the provision that gives FDA mandatory recall authority for foods as an example of tools the agency needs to do its job well (⁴ Also see "House Passes Food Safety Bill That May Not Be Appetizing To Senate" - Pink Sheet, 3 August, 2009.).

Is FDA Going Far Enough?

Council for Responsible Nutrition President and CEO Steve Mister praised Hamburg's comments that industry should make sure they have robust compliance systems in place.

Mister said in an e-mail the group has "long said that laws are only as strong as their enforcement, and though the majority of companies out there are playing by the rules, these steps can help level the playing field for the entire industry."

Daniel Fabricant, interim executive director at the Natural Products Association said, "It is key that the agency does more than just serve warning letters."

"There needs to be a real strong deterrent for folks that violate the law," he said, adding he was not sure the new initiatives were strong enough deterrents for some bad actors.

Violators will need to see severe sentencing, either federal fines or prison time, to be deterred, he said.

"In terms of enforcement, I would have loved to hear [Hamburg] say, 'We're going to do more inspections. We've got more money. And furthermore, while we appreciate the food safety bill, the food [good manufacturing practices] have not been updated in [23] years. We're going to look at that too,'" he said.

Fabricant also said he would have liked to hear that FDA "is going to work closely with the industry" to get rid of the "less than responsible players."

Mark Mansour, an attorney with Bryan Cave, also said it will be important that FDA communicate with manufacturers. "Enforcement needs to be fair, and a cooperative approach with industry is much more desirable than a one-way process that does not envision a dialogue with manufacturers," Mansour said in an e-mail.

FDA will benefit from discussions with industry about which actions are effective, Hamburg said.

- Katie Stevenson ( ⁵ k.stevenson@elsevier.com )

FDA Enforcement Follow-Through Could Thin Out Violators

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