FDA Law Update : FDA Regulation Lawyer & Attorney : Sheppard Mullin Law Firm : Food & Drug Administration Product Regulations

By Peter Reichertz

On July 14, 2010, Congressman Edolphus Towns introduced legislation to provide for the mandatory recall of adulterated or misbranded drugs. The legislation, H.R. 5740, has been referred to the Committee on Energy Commerce. Congressman Towns was the chair of the subcommittee that held hearings about Johnson & Johnson/McNeil and its handling of adulterated children’s drug products (including Tylenol® and Motrin®) this past Spring. Johnson & Johnson was scrutinized for delaying the recall of the products and allegedly covering up the recall of some of the products. As a result, there has been increased publicity over the authority of the U.S. Food and Drug Administration (“FDA”) to require the recall of drug products.
 

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By Deborah M. Shelton

For years, the Food and Drug Administration has maintained that it has jurisdiction over laboratory-developed tests (“LDTs”) – those in vitro tests developed, validated and used for in-house pathology and diagnostic purposes – as medical devices. Yet the Agency has, with some few exceptions (e.g., IVDMIAs), exercised enforcement discretion, reasoning that most LDTs were simple, well-characterized, and reliant upon various FDA-regulated individual components. As LDTs have become increasingly complex and the laboratory setting increasingly large-scale, FDA has begun rethinking its regulatory approach.

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By Deborah M. Shelton

For years, the Food and Drug Administration has maintained that it has jurisdiction over laboratory-developed tests (“LDTs”) – those in vitro tests developed, validated and used for in-house pathology and diagnostic purposes – as medical devices. Yet the Agency has, with some few exceptions (e.g., IVDMIAs), exercised enforcement discretion, reasoning that most LDTs were simple, well-characterized, and reliant upon various FDA-regulated individual components. As LDTs have become increasingly complex and the laboratory setting increasingly large-scale, FDA has begun rethinking its regulatory approach.
 

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In a recent interview, Senator Herb Kohl (D-Wis.), Chairman of the Senate Judiciary Committee's subcommittee on antitrust, competition policy and consumer rights, discussed the subcommittee's legislative priorities for 2010. At the top of the list is passage of the Preserve Affordable Access to Generics Act, which would prevent anticompetitive "pay-for-delay" patent settlements in which a brand-name pharmaceutical company pays a generic drug maker millions of dollars in exchange for an agreement to stop selling a generic version of the drug.
 

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Manufacturers

As part of the recently enacted Patient Protection and Affordable Care Act (“PPACA”) – known to most as Healthcare Reform Legislation, new taxes will be imposed on manufacturers of “branded prescription drugs” and most medical devices. These taxes are in addition to the fees already charged by the Food and Drug Administration (“FDA”) for review of full new drug applications for drugs and 510(k)’s and Premarket Approval Applications for medical devices. And unlike user fees, the taxes will not be paid to FDA but assessed by the Department of Treasury and paid to support health insurance coverage.
 

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On March 29, 2010, FDA published a proposed rule setting forth how it would interpret the Congressionally mandated requirement that “major statements” in broadcast Director-to-Consumer (“DTC”) advertisements for prescription drugs be presented in a “clear, conspicuous and neutral manner." See proposed 21 C.F.R. § 202.1(e), 75 Fed. Reg. 15376 (March 20, 2010).  
 

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In the wake of a scathing March 4^th GAO Report, FDA has informed Congress that it will boost criminal prosecutions of pharmaceutical and food industry executives.[1] Although the Agency’s Office of Criminal Investigation (OCI) can prosecute ‘responsible corporate officials,’ according to the GAO Report OCI has failed to exercise this enforcement tool to achieve FDA priorities and has underperformed comparable agencies in bringing misdemeanor prosecutions.
 

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On June 12, 2009, Congress passed a legislation empowering the Food and Drug Administration to regulate cigarettes and tobacco products. Just one day after the Senate approved the bill, the House decided to forgo its own version of the bill and passed the Senate bill with a final vote of 307-97. President Obama stated he will promptly sign the bill into law. Enactment of such legislation will end a long battle over the years to give FDA the authority to regulate the manufacturing, marketing and sale of cigarettes and other tobacco products. The bill, authorizes sweeping regulation of the tobacco industry.
 

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