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| January 2016 | |||||
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Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC office, and articles from members of AGG outside the Food and Drug Practice. In this Issue
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PHARMACEUTICALS While Not Quite a Rash of Enforcement, FDA Takes Action in 2015 Against Cosmetic Products Making Unapproved Drug Claims To paraphrase, admittedly horribly, the Cole Porter classic, “I’ve Got You Under My Skin,” a number of cosmetic companies got under the Food and Drug Administration’s (FDA) skin in 2015 for making unapproved new drug claims. While the number of Warning Letters issued in 2015 does not necessarily indicate a rash (pun intended) of new enforcement, the number was not insignificant and is a reminder that the agency regulates cosmetic product claims and will take action if it believes the promotional statements are unlawful. More > Merck Resolves Investors’ Class Action Lawsuit Related To Vioxx In 2004, Merck pulled its painkiller, Vioxx, from the market after a study linked the drug to increased risks for heart attack and strokes. On Friday, January 15, 2016, Merck announced that it had agreed to pay $830 million to settle a federal class action lawsuit in New Jersey filed by investors who claimed that the company had made misleading statements about the drug’s safety. The plaintiff-shareholders had bought stock in the company between May 21, 1999 and Oct. 29, 2004. In 2011, the court ruled they could proceed under the federal securities laws based on their claims that Merck misled them about a 2000 study that reported that Vioxx caused five times more heart attacks than another painkiller, naproxen. More > | ||||
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MEDICAL DEVICES FDA Releases Draft Guidance on UDI Requirements for Convenience Kits On January 4, 2016, the Food and Drug Administration (FDA) released a draft guidance intended to clarify the Unique Device Identifier (UDI) labeling requirements for certain medical devices packaged together as “convenience kits.” The draft guidance, while not legally binding, attempts to explain FDA’s current thinking on the regulatory exception to the UDI Final Rule, whereby devices packaged within the immediate container of a convenience kit are exempted from UDI labeling requirements, if the label of the convenience kit contains a UDI. More > | ||||
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NEWS FROM WASHINGTON The Department of Justice is Committed to Protecting Consumers from “Bad Medicine” Last month, the Acting Associate Attorney General Stuart F. Delery, announced that the Department of Justice (DOJ) would continue to target illegitimate online pharmacies, which pose a threat to drug safety and undermine consumer confidence. Delery noted that illegitimate online pharmacies can create several types of dangers, including dispensing the wrong drugs, and/or drugs that contain harmful contaminants, lack the active ingredient, have expired, have become degraded by improper storage, or have been delivered without dosage warnings or instructions. As evidence of the DOJ’s ongoing commitment to protecting American consumers from illegitimate online pharmacies, Delery also highlighted two recent cases involving international online pharmacies that distributed adulterated and counterfeit drugs in the United States. More > | ||||
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