Articles Posted in Radiation-Emitting Products

3699948229_d7732f8df0_o.jpgOn April 30, FDA published in the Federal Register final regulations amending the scope of its clinical investigator disqualifications. Now when the Commissioner determines that a clinical investigator is ineligible to receive one kind of test article (drug, device, animal drug), the clinical investigator is also ineligible to conduct any clinical investigation that supports an application for research or marketing for other FDA-regulated products, including foods and tobacco products. FDA amended its regulations “to protect the rights and safety of subjects involved in FDA-regulated investigations, and help[s] to ensure the reliability and integrity of the data used to support the marketing of products regulated by FDA.”

According to FDA, the final rule was based on a recommendation from the General Accounting Office (“GAO”) in September 2009. The GAO Report, Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA’s Debarment and Disqualification Process for Medical Product Investigators, stated that it was “critical for FDA to take action–and to have the authority to take action–to prevent clinical investigators . . . who engaged in serious misconduct from doing it again, whether in research that involve drugs, biologics, or devices.” FDA is also amending its regulations for informal hearings under 21 C.F.R. Part 16 by changing the scope of certain provisions that were “inadvertently omitted.”

FDA proposed the rule in the Federal Register on April 13, 2011 and received only two comments. FDA, however, managed to convert one of the filed comments to ten points to address in the preamble to the final rule. First, FDA clarified the “repeatedly or deliberately” language in the regulations for when a clinical investigator may be disqualified for repeatedly or deliberately failing to comply with FDA’s applicable clinical investigations regulations or deliberately submitting false information to the sponsor. FDA said “repeatedly” means more than once, which can be more than one time in a single study or in more than one study. “Deliberately” means “willful” conduct or with reckless regard, such as knowingly failing to comply with FDA’s regulations or falsifying data. In another point, FDA clarified that FDA will place no limits on how far back FDA will investigate to find applications or submissions that may have been affected by a disqualified investigator. In yet another point, FDA summarized the notification process for how sponsors become aware of an clinical investigator’s ongoing disqualification process, including redacted letters on FDA’s website. In the final point, FDA indicated how FDA notifies sponsors that clinical investigators have been reinstated–once again, primarily FDA’s website.
Continue reading

FLH Partner Brian Malkin will attend the Food and Drug Law Institute’s (“FDLI’s”) Annual Conference in Washington, D.C. on April 24-25. For 55 years, FDLI’s Annual Conference has been considered the venue for food and drug law lawyers and professionals to hear from FDA and industry about new and emerging topics covering all the products FDA regulates. FDLI has reported that this year’s event is expected to draw more than 600 attendees, who will hear directly from FDA’s key leaders including Commissioner Margaret Hamburg; Deputy Commissioners Deborah Autor, Stephen Spielberg, and Michael Taylor, various representatives from FDA’s six product Centers; newly-appointed Chief Counsel Eliabeth Dickinson, as well as a number of former Chief Counsels. An updated agenda is available here.

FDA Lawyers Blog is a Media Partner of FDLI’s 55th Annual Conference. Prior to FDLI’s Annual Meeting, Mr. Malkin will participate in a FDLI Monograph Committee Meeting on April 23 and will be working out of Frommer Lawrence & Haug LLP’s Washington, D.C. office next week. Mr. Malkin looks forward to seeking you and catching up at FDLI’s Annual Conference this year.


fdli2011_fullheader.jpgThe Food and Drug Law Institute’s (“FDLI’s”) Annual Conference starts in just two weeks in Washington, D.C. on April 5-6. As media partner for the program, FDA Lawyers Blog knows the importance of attending this Annual Conference each year.

The Conference is packed full with a range of topics including: a report-out from the Government Accountability Office, the new Consumer Product Safety Commission (CPSC) product safety database, Drug Enforcement Administration (DEA) scheduling, global supply chain integrity, nutrition label regulations and biosimilars regulation.

For more than 50 years, FDLI’s Conference has provided the venue for food and drug law professionals to discuss and debate emerging topics, as well as participate in great educational sessions At this year’s event, attendees will hear directly from FDA leadership including Commissioner Hamburg, Chief Counsel Tyler and FDA’s six product center directors.

by Andrew M. Nason

TSA images.jpg The debate over the Transportation Security Authority’s (“TSA’s”) new X-ray scanners has quieted somewhat since the Thanksgiving holiday, but with Christmas around the corner, it may heat up once again. Along with privacy concerns associated with government officials viewing essentially naked images of the traveling public during the screening process, concerns remain over the safety of TSA’s new scanning technologies. TSA has remained steadfast in its position that both variations of its new machines–those using backscatter x-rays as well as those using millimeter wave technology–pose at most a miniscule risk. FDA says the X-ray machines emit a radiation dose roughly equivalent to the radiation people expose themselves to in 42 minutes of every day living, and that “no known adverse health effects” are associated with millimeter wave technology.

Most scientists and researchers agree in general with TSA’s safety claims. Dr. Richard Morin, a radiation specialist at the Mayo Clinic in Jacksonville, Florida, called the levels of radiation emitted by both machines “pretty much insignificant.” At least one scientist has questioned, however, the need to use technology that poses any risk at all when a risk-free alternative exists. David Brenner, director of Columbia University’s center for radiological research, said despite the very low individual risk, factoring in the number of people exposed to that risk, a certain number of people likely will end up with a cancer from the radiation exposure. This might be an acceptable return for air security if an alternative with no known health risk–the millimeter wave machines–did not exist.

Other scientists have criticized TSA and FDA for not demonstrating adequately the machines’ safety, and called into question comparisons between the scanners and other types of radiation. A group of doctors and scientists from the University of California, San Francisco (“UCSF”) wrote a letter to President Obama’s chief scientific advisor indicating that the machines may pose more danger than anticipated because of the different type of radiation involved. The X-rays in the TSA scanners, unlike other radiation, operate at low beam energies, which means they deliver most of their energy to the skin and underlying tissue, not to the entire body. Because the skin and adjacent tissue represent such a small fraction of body weight, the dose to the skin may be one to two orders of magnitude higher than expected from the total radiation emissions.
Continue reading