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

By Mike Emmick

In the fervor of the U.S.'s current anti-foreign-corruption efforts, a particularly misguided proposal has occasionally reared its ugly head: Requiring “mandatory debarment” for any company that violates the Foreign Corrupt Practices Act (“FCPA”).

On the merits, such a proposal is completely wrong-headed. Debarment is a severe, forward-looking administrative remedy – the corporate “death penalty” – not a vehicle to “boost” the penalties for past criminal FCPA violations.

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By Mike Emmick and Joseph Barton

Corporate executives in the health care and environmental industries are rapidly coming to appreciate the implications of the responsible corporate officer doctrine, a recently-revitalized weapon in U.S. Department of Justice’s battle against corporate crime.

This doctrine is a peculiar exception to the usual requirements for a criminal prosecution. Ordinarily, criminal law requires a defendant to have committed a criminal act, and to have done so with criminal intent.

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By Robert Uram

On March 27, 2012, the comment period will close on a petition filed by the Center for Food Safety that calls for the FDA to issue new regulations requiring labeling of all foods produced using genetic engineering (GE). Docket No. FDA-2011-P-0723 (Filed October 12, 2011). Unlike many other developed countries – such as 15 nations in the European Union, Japan, Australia, Brazil, Russia and even China – the U.S. has no laws requiring labeling of genetically engineered foods.

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By Seth A. Mailhot

Welcome to the next monthly installment in FDA's enforcement of regulated tobacco products. This month we will examine some of the differences found between different states in FDA enforcement actions against retailers.

Sheppard Mullin has been closely monitoring FDA's tobacco enforcement actions to better serve its clients. From the beginning of FDA's program inspecting tobacco retailers, a trend emerged suggesting that there are significant differences in enforcement between retailers depending on the state in which the inspection was conducted. This raises concerns about not only in how each state conducts its retail inspection program, but the level of oversight applied by the Center for Tobacco Control over the program as a whole.

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Welcome to the first monthly update on FDA's enforcement over regulated tobacco products. This update will examine trends in Warning Letters, and cover some unique Warning Letters and enforcement actions that have occurred in the previous month. As the first post regarding tobacco products, we begin with an alert regarding FDA's issuance of civil money penalty complaints. The update also provides a summary of tobacco related Warning Letters issued by the FDA to date.[1]

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By Peter Reichertz

FDA has at last began formal implementation of the Biologics Price Competition and Innovation Act of 2009 ("BPCI Act"), by announcing the proposal it will send to Congress to implement user fees for "generic" copies of biologics, called biosimilars in the BPCI Act. A biosimilar is a product approved under Section 351(k) of the Public Health Service Act ("PHSA"); approvals are not Federal Food, Drug and Cosmetic Act ("FFDCA") approvals. Under the proposal, the user fees for biosimilars - including the product application fee, the annual product fee and the annual establishment fee - would be identical to the fees established for human drug products approved under Section 505(b) of the FFDCA with one significant difference.[1]

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By Gray Buccigross

The Federal Circuit issued its opinion in Classen Immunotherapies, Inc. v. Biogen Idec, 2011 U.S. App. Lexis 18126, on August 31, 2011. As part of that decision it held that the safe-harbor provision of the Hatch-Waxman Act is limited to activities reasonably related to obtaining pre-marketing FDA approval of generic counterparts, and does not protect post-approval research activities.

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By Peter S. Reichertz

In a Federal Register notice of September 7, 2011,[1] the Office of Human Research Protection (“OHRP”) and the Food and Drug Administration have clarified that a waiver by an individual in an informed consent to compensation for use of his/her biospecimens is not “exculpatory”, and permissible, if worded properly. This Guidance – entitled “Guidance on Exculpatory Language in Informed Consent" – applies to research conducted for purposes of FDA approval, as well as research sponsored by the Department of Health and Human Services (“DHHS”).
 

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By Seth A. Mailhot

On Friday, July 29, 2011, the Institute of Medicine of the National Academies (IOM) released its long awaited report on the premarket clearance process under section 510(k) of the Federal Food Drug and Cosmetic Act.[1] The premarket clearance submission, commonly known as a 510(k), allows manufacturers to market a medical device based on its similarity, or “substantial equivalence,” to one or more marketed devices (called “predicate devices”). The 510(k) process is the most widely used pathway for marketing medical devices through the U.S. Food and Drug Administration (“FDA”), and is intended for intermediate risk devices.[2] The report was anticipated to provide clear action items to the agency to strengthen the 510(k) process and make it more responsive to companies developing emerging medical technology. Instead, the recommendations made by the IOM committee only heighten the current uncertainty with the future direction of the 510(k) process.
 

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By Peter S. Reichertz

The Supreme Court ruled on June 23, 2011, that generic drug manufacturers cannot be sued for a failure to warn under state tort law, as long as their labeling complies with the FDA mandated labeling for the innovator drug product. While the Court had previously declined to find that federal regulation and approval of drug labeling of an innovator drug preempted state tort law in Wyeth v. Levine, 555 US 555 (2009), the Court ruled 5-4 in Pliva that the comprehensive scheme for approval of generic drugs under the 1984 Hatch-Waxman amendments required generic manufacturers to use the same labeling as the innovator brand name product. Since the law and FDA regulations, as conceded by the Food and Drug Administration (FDA), preclude a generic company from obtaining approval of labeling different from the innovator brand name product, the Court held it was not possible for a generic manufacturer to comply with both federal and state law. As such, under the doctrine of impossibility, they ruled federal law was supreme and state tort laws on failure to warn were preempted. In so finding, they held that the issue of “impossibility” turns on whether the private party could independently do under federal law what state law requires of it. In this case, they held that generic manufacturers could only ask FDA to change labeling and could not do so without FDA approval, and thus could not act independently.
 

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By Seth A. Mailhot and Allie Frumin

On June 14, 2011 the U.S. Food and Drug Administration (FDA) announced new requirements for sunscreens and sunscreen-containing products currently sold over-the-counter. These changes are covered in a Federal Register notice to be published on June 17, 2011. The Final Rule will have a significant impact on producers of sunscreens and cosmetics and will result in changes to labeling, advertising and formulation of a vast array of products containing sunscreen and making sunscreen claims. In addition to the Final Rule, which will take effect for most producers on June 18, 2012, the FDA has also developed a Proposed Rule, an Advance Notice of Proposed Rulemaking and a Draft Guidance for Industry regarding these products.
 

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By Peter S. Reichertz and Allie Frumin

On March 22, the U.S. Supreme Court affirmed the Ninth Circuit’s ruling in Matrixx Initiatives, Inc. v. Siracusano, 09-1156. See our prior blog article from November 18, 2010.
 

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By Peter S. Reichertz and Allie Frumin

January 19, FDA announced its plan to modify the 510(k) “approval” pathway, the most common review path for medical devices. Specifically, FDA released a report containing twenty-five actions it intends to take in 2011 to “improve” the review process. Importantly, however, no changes have yet been made to the process; FDA has just announced its plan of action of how it intends to address potential changes to the process.
 

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By Deborah M. Shelton

In the flurry of legislation passed by the 111^th Congress in its final days, the Food Safety and Modernization Act (FSMA) cleared the Senate by unanimous voice vote on December 20, passed the House 215-144 the following day, and was signed into law by President Obama on January 4, 2011 ("date of enactment"), immediately upon returning from his holiday vacation in Hawaii.
 

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