FDA Warns In Recall Guidance Agency Has Arsenal Of Enforcement Options

FDA warns that even though it cannot mandate a drug recall, "it can take more authoritative legal actions" against firms selling defective health products.

A guidance published in question-and-answer format Aug. 9 is "a warning shot across the bow" to industry that the agency will aggressively pursue noncompliance and enforce its current recall authority, said Gene Grabowski, senior VP and head of the crisis and litigation practice at Levick Strategic Communications.

FDA issued the ¹ document as McNeil Consumer Healthcare's ongoing recall of Children's Tylenol continues to draw attention to the agency's recall authority and procedures.

FDA emphasizes through a series of questions and answers about the recall process that it "expects that a firm will voluntarily recall a drug that is defective or flawed if it could be hazardous to health," and if it does not, the agency can seize the product or pursue a court injunction.

The agency also can compel recalls by enforcing several good manufacturing practice provisions, including a requirement firms establish and follow written procedures to facilitate the recall of defective products, according to the guidance. If a firm does not have a recall policy or does not follow the policy, it violates the GMPs.

The guidance further "clarifies that FDA's recall procedures cover all regulated drugs, including over-the-counter monograph drugs," an agency spokeswoman said.

Cloudy On Serious Adverse Event

While the guidance evokes the question of what is a serious adverse event, it fails to clarify the issue substantially.

Confusion about whether a reported adverse event is serious contributed to delays in Matrixx Initiatives' recall of Zicam zinc-containing nasal gel and gel swab products in June 2009 (² (Also see "Zicam Case Shows FDA Takes Defining Adverse Events Seriously" - Pink Sheet, 22 Jun, 2009.)).

FDA said the adverse event - anosmia, or loss of smell - was permanent in some cases, which qualified it as serious. FDA officials inspecting Matrixx's Scottsdale, Ariz., plant found the anosmia complaints among the approximately 800 consumer AERs the firm had received but not submitted to the agency.

In a separate guidance, the agency defines serious adverse events as cases involving death, life-threatening circumstances, hospitalization, disability, congenital anomaly or permanent impairment or damage. It gives firms 15 days to report these events.

FDA could use this information to determine if a recall is necessary and, if so, request one or take other action - as it did in the Matrixx case.

FDA also reminds industry in the guidance that "manufacturers also must establish and follow written procedures for periodically reviewing complaints, recalls, returned or salvaged drug products and investigations of product discrepancies," which include reviewing an "appropriate number of batches."

The guidance specifically notes that under the drug GMPs, manufacturers must report quality defects for OTC products approved in a new drug application.

The agency also notes firms are required to submit information to FDA on serious adverse events that consumers report associated with monograph OTC drugs. AERs for nonprescription drugs approved in applications also must be forwarded to the agency.

Q&A Addresses Multiple Audiences

Beyond informing industry, the guidance could serve to clarify how recalls are conducted for the public and legislators who are confused or critical about recent high-profile recalls, said Mike Rozembajgier, VP of recalls at consultancy ExpertRECALL.

He explained that consumers likely have grown more concerned about product safety in the wake of the McNeil, Matrixx and other recent high-profile recalls, including the unprecedented recall of salmonella-tainted peanut products that began in January 2009 and that continues to affect firms manufacturing and distributing products in the U.S.

The public is asking "why are they occurring, why are there so many occurring, how is this fixed and, at some point or another in that logical sequence, people start to think about the agency that is overseeing this" and what it is doing to improve the situation, Rozembajgier observed.

FDA also has drawn criticism from the House Oversight and Government Reform Committee for not identifying sooner McNeil's manufacturing violations that led to the recalls.

At a May hearing, FDA Principal Deputy Commissioner Josh Sharfstein told the committee the agency is improving its recall activities and strengthening enforcement, but needs additional authorities (³ (Also see "FDA To Toughen OTC Oversight, Seek New Authority In Wake Of J&J Recalls" - Pink Sheet, 31 May, 2010.)).

The guidance reinforces Sharfstein's message that FDA will enforce more aggressively existing recall authorities, many of which appear to exist within GMP inspections, but does not undermine agency executives' support for strengthening FDA's enforcement powers.

Rather, the agency emphasizes several times in the guidance that it cannot mandate a recall.

Following Sharfstein's testimony that FDA could use additional powers, Oversight and Government Reform Committee Chairman Edolphus Towns, D-N.Y., introduced legislation, H.R. 5740, to authorize FDA to mandate recalls of adulterated, misbranded or potentially unsafe drugs (⁴ 'The Tan Sheet' July 19, 2010).

Sen. Michael Bennet, D-Colo., also proposed legislation that would authorize FDA to order drug recalls (⁵ (Also see "Senate Bill Expands FDA's OTC Manufacturing Oversight" - Pink Sheet, 9 Aug, 2010.)).

The agency currently has the power to order recalls of medical devices, but not drug or food products

Bennet's bill also seeks to strengthen FDA oversight of OTC GMP compliance by prohibiting the agency from basing inspection decisions on whether a facility makes Rx or OTC drugs.

OTC drugs "should not receive less oversight, as we learned from the Children's Tylenol recall," Bennet said when he introduced his bill, S. 3690.

- Elizabeth Crawford ( ⁶ [email protected] )