Topic
Patient Access
26 published works
Health Industry Washington Watch
HHS Finalizes Healthcare Interoperability and Information Blocking Rules
By Nancy Halstead, Vicki Tankle
The U.S. Department of Health and Human Services (HHS) issued eagerly anticipated and hotly debated companion interoperability and information blocking final rules that are expected to transform the way in…
Health Care and Life Sciences
The FDA Looks Inward as It Tackles Interoperability
Interoperability and patient access to data has been pushed to the forefront as a primary concern for the health industry. This is largely due to proposed rules published this spring…
Focus on Regulation
Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry
The treatment of patients with unapproved therapies is often referred to as “compassionate use” or “expanded access”. Under right-to-try laws, state-level legislation has paved the way for a new law…
DEA Chronicles
Bipartisan Agreement that News Reports Regarding the Ensuring Patient Access and Effective Drug Enforcement Act are Light on Facts
On December 12, 2017, the Senate Judiciary Committee held an oversight hearing to discuss the Ensuring Patient Access and Effective Drug Enforcement Act (the "Act"). The Act has been the…
Health Care Law Matters
Regulatory changes allow patients greater access to medical marijuana in New York state
The New York State Department of Health recently announced two regulatory enhancements to improve patient access to medical marijuana. On March 22, 2017, chronic pain was added as a…
Health Industry Washington Watch
Congressional Health Policy Hearings
The Senate HELP Committee is holding a January 28, 2016 hearing on “Generic Drug User Fee Amendments: Accelerating Patient Access to Generic Drugs.” Separately, on February 4, the House Committee…
Health Industry Washington Watch
House Approves “Ensuring Patient Access and Effective Drug Enforcement Act”
On April 21, 2015, the House of Representatives approved H.R. 471, the Ensuring Patient Access and Effective Drug Enforcement Act of 2015. The bipartisan legislation would clarify the Controlled Substances…
DEA Chronicles
Legislation Introduced in Senate Seeking to Amend CSA
On February 12, 2015, Senators Hatch and Whitehouse introduced the Ensuring Patient Access and Effective Drug Enforcement Act of 2015. This is the companion bill to H.R. 471, sponsored by…
DEA Chronicles
Defining, but Protecting, DEA’s Suspension Powers: the Impact of HR 4069
The "Ensuring Patient Access and Effective Drug Enforcement Act" introduced by Representatives Blackburn and Marino defines the term "imminent danger." The Controlled Substances Act requires DEA to find that a registrant…
Reproductive Rights Prof Blog
10th Anniversary of RU-486: Where are We Going from Here?
The Root: 'Abortion Pill' Controversy Stirring on 10th Anniversary, by Nsenga Burton: On the 10th anniversary of the FDA's approval of RU-486, anti-abortionactivists are up-in-arms over the fact that RU-486…