Tag Archives: FDA

FDA User Fee Reauthorization Poised To Pass House of Representatives

On Monday, the House of Representatives released the latest version of the proposed Food and Drug Administration user fee reauthorization bill. The House is expected to vote on the must-pass bill as early as today, but the Senate has not yet set forth its own timeline for voting on the bill.

July 12, 2017

‘Right To Try’ Won’t Give Patients Access To Experimental Drugs. Here’s What Will.

There are meaningful steps Congress can take to help desperate patients, such as educating doctors and patients about the FDA’s “expanded access” process and making it more appealing to drug companies, but the right-to-try bills, if passed, will do more harm than good.

May 3, 2017

Scott Gottlieb And The Goldilocks Theory Of Bringing Change To The FDA

With the nomination of Dr. Scott Gottlieb to head the FDA headed to the Senate floor, we can expect another Goldilocks debate about whether today’s FDA is too lenient, too tough, or just right in reviewing new prescription drugs.

May 1, 2017

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