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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Legislation
Generic Drug Manufacturers And Failure To Warn: What duty is there after Pliva v. Mensing?
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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Sunscreen in the Spotlight: FDA Illuminates New Sunscreen Regulations
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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A MATRIXX Revolution, Part II: Supreme Court affirms Ninth Circuit’s holding that life science companies cannot rely on a statistical significance standard when deciding whether adverse event reports are material for the purpose of securities disclosures
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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FDA Announces Its Plan For Changes to the 510(k) “Approval” Pathway
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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President Obama Signs New Expansive Food Safety Law
In the flurry of legislation passed by the 111th 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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E-CIGARETTES GET A “SMOKING” BREAK: D.C. Circuit Clarifies Scope of FDA’s Authority Over E-Cigarettes
By Deborah M. Shelton and Allie Frumin
On Tuesday December 7th, the D.C. Circuit Court of Appeals affirmed a lower court’s ruling in Sottera, Inc. v. FDA, No. 10-5032, (D.C. Cir. Dec. 7, 2010) holding that that the Food and Drug Administration (FDA) could not regulate as a medical device the electronic cigarettes (often referred to as “e-cigarettes”) at issue in that case. Instead, the court affirmed the district court’s finding that FDA’s authority over these e-cigarettes, as labeled, was limited to that over traditional tobacco products.
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IRS Guidance On New Excise Tax On Branded Pharmaceutical Companies: Filing Due January 21, 2011
In a prior article dated May 25, 2010, we advised of a new excise tax on branded pharmaceutical manufacturers. We indicated that the Patient Protection and Affordable Care Act ("PPACA") required the Internal Revenue Service ("IRS") to publish guidance "necessary to carry out the purpose" of the section in which the tax is included. The IRS has now issued that guidance ("the Guidance").
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A MATRIXX Revolution? Is there a need to describe all adverse event reports in SEC filings of life sciences companies?
The U.S. Supreme Court has scheduled oral argument for January 10, 2011, in the case of Matrixx Initiatives et al v. Siracusano, Case Number 09-1156, on appeal from the decision of the Ninth Circuit in Siracusano v. Matrixx Initiatives, Inc., 585 F3d 1167 (9th Cir. 2008). The court granted certiorari on July 14, 2010.
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FTC Changes Guidance on Environmental Marketing Claims
Many marketers of OTC drugs and devices, cosmetics, foods and dietary supplements make claims with regard to the content of their products and/or the packaging for their products. and their fate in or effect on the environment. These claims are regulated by the Federal Trade Commission (“FTC”) and its “false and misleading” authority found in Section 5 of the Federal Trade Commission Act. The FTC first issued its guidance on these rules in 1992, and revised them in 1996 and 1998.
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