On April 7, 2014, the Food and Drug Administration (FDA), in consultation with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC) released a draft report addressing a proposed strategy and recommendations on an “appropriate, risk-based regulatory framework pertaining to health information technology.”
Apple’s apps store lists close to a 100,000 health apps. Together with wearable technology, direct-to-consumer testing services, and greater consumer participation in the decision to purchase health insurance, the healthcare market in the United States is undergoing a significant transformation. Whether and how to regulate this evolving market is subject to substantial discussion and debate.
On November 15, 2013, the Federal Trade Commission (“FTC”) adopted special rules for determining whether “exclusive” licenses of pharmaceutical patents are required to be reported to the FTC and the Antitrust Division of the Department of Justice under the Hart-Scott-Rodino Premerger Notification requirements as asset transfers/acquisitions. See 78 Fed. Reg. 68705, et seq. While exclusive licenses of any patent regardless of industry have always been subject to reporting under the Premerger Notification rules as asset transfers/acquisitions, assuming they met the monetary thresholds for reporting, the FTC, adopted new rules specifically targeting exclusive licenses of patents of pharmaceutical companies.
The question every false claims defendant must face is whether to pursue litigation or simply concede and settle. While many shy away from litigation, opting for an expensive but certain resolution, for Johnson & Johnson and its subsidiary Janssen Pharmaceuticals, Inc., the decision to pursue their day in court has saved J&J over $330 million.
In our prior blog post of the same title on July 5, 2013, we predicted that the protection from product liability/failure to warn litigation for generic manufacturers as a result of the Supreme Court decision in Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013) might be short-lived. FDA, in a Federal Register notice dated November 13, 2013, has proposed to allow holders of Abbreviated New Drug Applications (“ANDA’s”) for generic drugs to file supplements for labeling changes that might cause its labeling – on at least a temporary basis – to differ from the labeling of its Reference Listed Drug. The proposed rule was published at 78 Fed. Reg. 67,985 and allowed for comments to be filed by January 13, 2014. By notice of Federal Register of December 27, 2013, 78 Fed. Reg. 78,796, FDA extended the comment date to March 13, 2014. What generic manufacturers need to know about this proposed rule is not only would it eliminate product liability protection, but it would increase their regulatory burdens.
The United States District Court for the Northern District of California ruled November 12, 2013, that a party seeking to obtain approval of a biosimilar could not avoid the process set forth in the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) by obtaining a declaratory judgment of patent invalidity before even submitting a biosimilars application. See Sandoz Inc. v. Amgen Inc., Civil No. 13-2894 MMC, _____ USLW _____ (N.D. Cal. 2013).
As computing power continues to become cheaper and more powerful, medical devices are increasingly capable of handling larger and larger sets of data. This provides the ability to log ever expanding amounts of information about medical device use and patient health. Whereas once the data that could be obtained from a therapeutic or diagnostic device would be limited to time and error codes, medical devices now have the potential to store personal patient health information. Interoperability between medical devices and electronic health record systems only increases the potential for medical devices to store personal information.
On August 5, 2013, the U.S. Food and Drug Administration published a final rule on the labeling of foods as “gluten free.” Gluten is a protein composite found in wheat, rye, barley, and their crossbred hybrids. Gluten gives elasticity to dough, helping it rise and keep its shape and often gives the final product a chewy texture. In order for a food to be labeled “Gluten Free” under the rule, the food may not contain 20 parts per million (ppm) or more gluten. The rule applies to the claims “free of gluten” and “without gluten” as well.
On July 25, 2013, the Food and Drug Administration (“FDA” or “the Agency”) published a Draft Guidance for Industry entitled “Pre-Launch Activities Importation Requests”, or “PLAIR”. The draft guidance describes FDA policy on requests for importation of unapproved finished dosage form drug products by an applicant preparing for market launch pursuant to a New Drug Application (“NDA”), an Abbreviated New Drug Application (“ANDA”) or a Biologics License Application (“BLA”). The draft guidance describes the procedure for making requests for importation prior to approval, as well as the factors FDA will look to in deciding whether to grant such requests.
On June 24, 2012, the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. Inc. v. Bartlett, 570 U.S. ____ (2013), finding that design-defect claims against generic drug companies are pre-empted where federal law prohibits an action required by state law. The Supreme Court had previously held in Pliva v. Mensing, 564 U.S. ____ (2011) that failure to warn claims against generic drug manufacturers are pre-empted by the Federal Food Drug and Cosmetic Act since generic drug makers must copy innovator drug labeling precisely in order to obtain approval of their products by the U.S. Food and Drug Administration (“FDA”). The Court in Mutual rejected the argument of lower courts that the generic manufacturer could comply with both federal and state law by choosing not to make and distribute the product at all.