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FDA announces multi-step response plan to mitigate abuse of pain killers

By attorney Mary Holloway Richard

In response to criticism that it has been too lenient in approving addictive narcotics and reticent to take action to mitigate abuse and overuse of these painkillers, the FDA announced on Friday a multi-step responsive plan of action:

  • It plans to convene an outside advisory committee to seek advice prior to approving new opioids that don’t have abuse-deterring properties.
  • It plans to convene a separate pediatric advisory committee to examine all proposed labeling changes related to children.
  • The FDA also intends to strengthen follow-up studies to provide more insight regarding safety, effectiveness of opioid’s long-term use and to step up physician training in order to mitigate over-prescribing practices.
  • Pharmaceutical companies will be encouraged to develop more painkillers that are less subject to abuse—difficult to break, crush and dissolve—and, therefore, more difficult to ingest quickly in large quantities by snorting or injecting.
  • Finally, the agency will engage in efforts to increase access to naloxone and other treatments to counteract the effects of heroin and opioid overdoses.

Some pundits suggest that this response by the FDA is designed to ease tense relations with senators and to prepare the way for confirmation of President Obama’s appointee for agency director. In the face of industry- and society-wide recognition of the “opioid epidemic,” even action potentially based upon self-serving agency motivation, if effective, will save lives and scarce resources.

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Attorney teaches Behavioral Health Law course at OCU

Attorney Mary Holloway Richard is teaching Behavioral Health Law at the Oklahoma City University School of Law this Spring semester.

The course will cover a broad spectrum of behavior health topics including: basic mental illness diagnoses, licensure laws related to behavioral health providers of all types, reimbursement and financing issues, liability concepts related to the dangerous patient, consent and release of information, social and community responses to mental illness and substance abuse disorders and current policy and regulatory developments in the field, Richard said.

In conjunction with the American Health Lawyers Association’s Behavioral Health Task Force of which she is Vice Chair, Richard plans to bring in speakers from across the state and give the class better exposure to the subject matter, to the larger context of the healthcare industry and to people who work in the field, she said.

This class follows Richard’s Fall course which was a survey and introductory course to Health Law.

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Attorneys support i2E 2015 BrewFest

Attorneys Monica Ybarra, Dawn Rahme, and Erica Halley at Brewfest

Attorneys Monica Ybarra, Dawn Rahme, and Erica Halley at Brewfest.

Hundreds of patrons filled the Chickasaw Bricktown Ballpark on Nov. 5 to support i2E’s (Innovation to Enterprise) annual OKBio BrewFest.

The intellectual activity surrounding the annual i2E BrewFest channels the exciting physical changes in downtown Oklahoma City, the Oklahoma Health Center, Bricktown, Deep Deuce and the state,” “Where else can you find entrepreneurs mingling to discuss their business plans and dreams with one another and with support professionals like the Phillips Murrah team that supports technical businesses as they establish themselves and expand?

-Mary Holloway Richard

“From conversations with a graduate student physiologist focusing on lessening the impact of retinitis pigmentosa to discussions with an OCU Botany professor and a young distiller known for his marketing genius who is expanding into new markets—all this on a beautiful fall evening at the ballpark.  Helping clients achieve their business goals in research, health care, product development is a exciting as it gets.”

Lauren Branch and her husband Phillips Murrah Director Doug Branch.

Lauren Branch and her husband Phillips Murrah Director Doug Branch at Brewfest.

The event featured samples from 23 of Oklahoma’s local craft beer, wine and spirits producers.

“OKBio BrewFest is an annual fall event to shine a spotlight on bio in Oklahoma and provide support for OKBio, which among other things provides BIO International scholarships to Oklahomans every year,” said i2E President Scott Meacham in an article about BrewFest.

Other event sponsors include Crowe & Dunlevy, Foundation HealthCare, Greater Oklahoma City Chamber, Oklahoma Gazette, Hall Estill, Caisson Biotech, Hit Design, VWR International, McAfee & Taft, Dunlap Codding, and Woodland & Associates.

Read more about BrewFest here.

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Attorney Mary Holloway Richard moderates webcast for OBA

Health Care Attorney Mary Holloway Richard hosted a webcast October 28 for the Health Law Section of the Oklahoma Bar Association.

“The presentation is entitled ‘Representing Vulnerable Populations: Behavioral Health Patients and Families,’ Richard said. “The webcast covers psychiatric diagnoses, emergency detention and involuntary admissions, confidentiality of information and other topics which will be useful to attorneys across the state called upon to represent behavioral health patients and their families.”

Richard served as moderator and presenter along with Judge Don Andrews, District Judge Oklahoma County formerly assigned to the Mental Health docket; Dr. Britta Ostermeyer, chairman Department of Psychiatry at the University of Oklahoma College of Medicine; and Dewayne Moore, general counsel of the Oklahoma Department of Mental Health and Substance Abuse Services.

The presentation was offered for Continuing Legal Education credit and will be made available by the OBA here.

 

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NewsOK Q&A: E-players enter health market

Published: August 19, 2015
By Mary Holloway Richard

Q: Is Google becoming a provider of health services?

A: One new Google product, “Helpouts,” allows consumers to search for clinical experts and then to video chat with those doctors. This project is in its final stages, and Google is working with some existing medical groups who are verifying the credentials of the doctors who are participating in the trial. The trial is limited to symptoms related to common conditions or diagnoses and a wide range of pediatric concerns. One pediatrician, for example, is available for free consultations with the goal of eliminating gaps created by isolated visits in favor of applied multidisciplinary expertise. Not all of the offerings are related to health care and not all of them are free.

Q: What’s the impetus for this expansion by Google and presumably other technology companies?

A: A consulting company, PWC, has referred to this trend as a move toward “… building a new health economy centered around the consumer.” Stated another way, there are patient needs to be met and patient populations to be built by providers. This is likely to bring new players into local, state and regional health care communities who may position themselves to receive revenue from shrinking health care dollars. For example, Walmart is experimenting with health conglomerate Kaiser Permanente to access physicians via Skype in two of its California locations. Providers who’ve petitioned the Department of Health and Human Services to allow Affordable Care Organizations to be reimbursed for “connect care” argue that it will improve quality and reduce costs. Providers participating in the Medicare Shared Savings Program can’t currently bill for services provided using advanced technology.

Mary Holloway Richard is recognized as one of pioneers in health care law in Oklahoma. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

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