Tag Archives: FDA

Scott Gottlieb’s FDA Commissioner Confirmation Hearing: Remarkably Unremarkable

In a presidential administration whose confirmation hearings have sparked more than a few contentious moments, FDA Commissioner-designate Scott Gottlieb’s confirmation hearing was remarkable for how unremarkable it was. But to say the hearing was uneventful is not to say that it was uninteresting.

April 7, 2017

Strategies To Address The Challenges Of Outcomes-Based Pricing Agreements For Pharmaceuticals

Outcomes-based pricing agreements may both improve access to treatments for patients who derive the greatest benefits from them and strengthen pharmaceutical companies’, clinicians’, and insurers’ interest in discouraging the use of ineffective therapies. However, stakeholders are missing...

April 3, 2017

‘I’m Willing To Try Anything’: Compassionate Use Access To Experimental Drugs And The Misguided Mission Of Right-To-Try Laws

Pharmaceutical companies, not the FDA, are the true gatekeepers for their proprietary products. Policymakers must take this into account and incentivize pharmaceutical companies to provide greater access to their products in development.

March 27, 2017

Prescription Drug Regulation, Promotion, And Advocacy Has Gotten More Vexing In 2017

Early 2017 has been one of the most interesting and challenging times for anyone concerned with medication regulation and evidence-based prescribing — as well as for the patients and health care professionals who will be so heavily impacted recent policy changes.

March 23, 2017

21st Century Cures Act Lowers Confidence In FDA-Approved Drugs And Devices

While it is difficult to ignore the positive aspects of the 21st Century Cures Act, there is also legitimate cause for concern that the traditional regulatory standards we have come to rely on may be modified, with unknown long-term effects on the safety and efficacy of new drugs and devices.

February 14, 2017

The Current 21st Century Cures Legislation Is Still A Bad Deal For Patients

We believe the bill’s potential benefits and modestly enhanced funding for scientific advancement are far outweighed by the increased risk of patient harm, and added pressure on the FDA to rush new products to market without adequate evidence.

November 30, 2016

The Cost Of A Cure: Revisiting Medicare Part D And Hepatitis C Drugs

Using new data released by CMS, we consider both the ongoing impact of hepatitis C drugs for Part D and the broader implications for Medicare of new high-priced drugs entering the market.

November 3, 2016

The FDA’s Controversial Duchenne Drug Approval And The Moral Impulse To Rescue

What can we learn from the Food and Drug Administration’s controversial approval of the first drug for Duchenne Muscular Dystrophy (DMD)?

October 25, 2016

Keeping A Finger On The PULSE Of Blood Donation Policy After Orlando

Following the mass shooting at a gay nightclub in Orlando, the FDA requested public comment on its current blood donation policies, including its policy on blood donations from gay men. This is a significant opportunity to modernize the FDA's policies by adopting an evidence-based approach that...

September 1, 2016

FDA Sanctions Off-Label Drug Promotion

Heightened constitutional protection of commercial speech in the health care arena has opened up opportunities for off-label promotion without threat of liability. The recent settlement between the FDA and Amarin Corporation is the most recent example of this trend.

July 19, 2016