On Wednesday, October 25, Judge Vince Chhabria, federal district court in San Francisco, rejected a request for a preliminary injunction by 18 states and the District of Columbia to compel the Trump Administration to continue to pay cost-sharing reduction (CSR)
October 2017
Senators Alexander and Murray release draft bill intended to stabilize the ACA marketplaces
On October 17, Senate Committee on Health, Education, Labor, and Pensions Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA) announced a bipartisan proposal intended to stabilize Affordable Care Act (ACA) marketplaces and relax ACA State Innovation Waiver restrictions.…
South African Health Products Regulatory Authority Board has been appointed
The Minister of Health has appointed the board members of the newly established South African Health Products Regulatory Authority (SAHPRA). This health agency is the successor to the Medicines Control Council (MCC) which for decades has been the only medicines…
Texas Medical Board proposes new telemedicine regulations
The Texas Medical Board (“TMB”) recently proposed new telemedicine regulations (the “Proposed Regulations”). Such regulations are necessary to revise current regulations of the TMB in light of Senate Bill 1107 (“SB 1107”), which recently passed the Texas Legislature.
I. Prescriptions
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President Trump announces end of cost-sharing reduction payments to insurers; President signs executive order promoting association health plans
On October 12, President Trump announced in a filing by the Department of Justice in the ongoing litigation challenging the cost-sharing reduction (CSR) payments that such payments will no longer be made to insurers. CSR payments help offset deductibles and…
FDA commissioner discusses greater scrutiny of health claims on food packaging
On October 10, 2017, the U.S. Food and Drug Administration (“FDA”) Commissioner Scott Gottlieb spoke at the Wall Street Journal Global Food Forum (“Forum”) and shed light on his views regarding food labeling.
Specifically, Dr. Gottlieb said that he wants…
FDA releases new guidances on increasing generic drug competition
The United States Food and Drug Administration (“FDA”) released four new draft guidances on October 2, 2017 that aim to reduce the barriers for certain generic drugs to enter the market and ultimately, reduce drug prices. Reducing drug prices was…
Ontario introduces legislation requiring disclosure of payments to physicians
Following a consultation, legislation was introduced in the Ontario Legislature on September 27, 2017 that will require pharmaceutical and medical device manufacturers to disclose financial relationships to healthcare professionals and organizations.
The Health Sector Payment Transparency Act is one…
Bakery receives Warning Letter for listing “love” as an ingredient
The US Food & Drug Administration does not have much of a sense of humor when it comes to the mandatory ingredient list on packaged food products. Last month, FDA issued a Warning Letter to the Nashoba Brook Bakery in…
U.S. Senate Republican leadership decides against full Senate vote on Graham-Cassidy ACA repeal and replace legislation; HHS Secretary Tom Price resigns under pressure from the White House
On Tuesday, September 26, Senate Republican leadership decided not to hold a full Senate vote on the Graham-Cassidy Affordable Care Act (ACA) repeal and replace legislation. The previous day, Monday, September 25, the Senate Finance Committee held a hearing…