Category Archives: Regulatory

MMA: No Longer Just An Acronym for Mixed Martial Arts, Mobile Medical Apps May Own That Sooner Rather Than Later

Mobile device software (apps) that give nursing home doctors access to drug reference databases help prevent serious and potentially life-threatening medication errors. That was one of the findings of a recent study published in the Journal of the American Medical Director’s Association (JAMDA), which also found that use of the drug reference apps was fairly routine for the physicians with access to them. The researchers found that nursing home physicians who used drug reference apps were more aware and less likely to give medications…

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Generic Drug Manufacturer Loses Battle on Preemption, But Wins War on Causation

Are state law claims against a generic drug manufacturer preempted where labeling of the generic drug differs from the brand name drug labeling?  In a recent drug liability case decided in the federal district court in Arizona, the court said no and held that the plaintiff’s claims were not preempted.  Nevertheless, the court concluded that the plaintiff’s physicians did not read or rely on the labeling and, therefore, Arizona law required dismissal of the plaintiff’s claim.  The case is Carter v. APP Pharmaceuticals and can…

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Does a Medical Device Manufacturer Have a State Law Duty to Advise the FDA of Post-Market Problems? The U.S. Supreme Court May Tell Us

This week, the U.S. Supreme Court has asked the Solicitor General to comment about whether a state law personal injury claim against a medical device manufacturer for a post-market failure to warn the FDA of a subsequently-discovered potential problem is preempted by federal law.  While any pre-market duty to warn claim for an FDA-approved medical device is pre-empted, there is an open question as to whether a state law claim can be pursued against a medical device manufacturer for failure to inform the FDA of…

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Are (Legally) Imported Prescription Drugs a Thing of the Future: Maine Thinks So

Maine has passed a law that takes effect today which permits the direct purchase of prescription drugs from certain foreign pharmacies. More specifically, the law exempts foreign pharmaceutical vendors from state pharmaceutical licensing laws. The law, which is noted to be the first of its kind, has come under attack from the pharmaceutical industry. Drug makers argue that consumer safety will be lost if the purchase of drugs from foreign pharmacies is allowed and that FDA oversight is impinged upon by the new law. The…

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FDA Largely Shutdown

With the Federal Government on shutdown, the FDA is largely shutdown as well. The FDA’s official announcement regarding the shutdown states that in the absence of either a 2014 fiscal year appropriation or an FDA specific Continuing Resolution, the FDA’s activities going forward will be limited to the following;

  • emergency work involving the safety of human life or protection of property;
  • criminal law enforcement work; and
  • activities funded by carryover user fees under certain acts such as the Prescription Drug User Fee Act.
Until an…

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New FDA Guidelines on Medical Device Mobile Apps

Scores of apps are available in the iTunes Store and the Android equivalent that are related to health and well being. This past week FDA issued a guidance (FDA Guidance for Mobile Apps) for Mobile Medical Applications which provides critical and much needed guidelines for industry as to which mobile medical apps are and are not going to be regulated by FDA as a medical device.  Last Thursday the FDA also engaged in a Twitter chat meeting for a question and answer session…

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European Union’s Proposed Regulations Governing Medical Devices Raise Multiple Concerns for US Manufacturers

On September 25, 2013, the European Parliament Committee on the Environment, Public Health and Food Safety (“ENVI”) voted on draft Regulations including a proposal concerning high risk medical devices, raising concerns among US manufacturers. Expectations that a more restricted process in Europe could undermine the development of domestic medical devices appear increasingly well-founded, but the entire story has yet to be played out overseas. At issue is an attempt by the European Union (“EU”) to close loopholes that allowed breast implants made with industrial-grade silicone…

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FDA Issues Final Rule on Unique Device Identifiers for Medical Devices

On September 20, 2013, the Food and Drug Administration issued a final rule implementing a unique device identifying (UDI) system to identify and track medical devices.  There are two main aspects to these new regulations: (1) rules related to what, when and how devices are to be labeled; and (2) a database designed to identify and track all UDI devices.  The overarching goal of these new rules is to improve the quality of information in adverse event reports, identify problems more quickly, expedite recalls…

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FDA Issues Guidance for Wireless Technology in Medical Devices

The Federal Drug Administration issued a guidance for Radio Frequency Wireless Technology in Medical Devices.  The guidance does not establish legally enforceable responsibilities but describes the FDA’s current thinking on this topic. The guidance document addresses a myriad of considerations that may affect the safe and effective use of medical devices that incorporate wireless technology, including the selection of wireless technology, quality of wireless service, coexistence with other wireless technologies, security and electromagnetic compatibility.  Citing 21 CFR 820.30, which regulates design controls, the FDA…

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Beware: Claims of Efficacy of “Off-Label” Uses of Hyperbaric Oxygen Therapy

Hyperbaric oxygen therapy (HBOT), which involves exposure of the body in a chamber to 100% oxygen under pressure, is widely know as a treatment for “the bends,” the common name for decompression illness in divers. The FDA long ago approved this use of HBOT.  The benefit obtained from HBOT for that and other approved uses derives from injured tissue being exposed to up to three times greater oxygen than is dissolved in the blood through breathing ordinary oxygen at normal air pressure. Hyperbaric chambers are…

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