‘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

A Strategy For Lowering Brand Drug Prices: Patent Buyouts And Licensing

Why does competition among brand drugs often fail to reduce prices? Creating nonprofit entities to purchase the intellectual property rights to any one of several competing brand drugs and license those rights to multiple generic manufacturers could both increase competition and lower prices.

April 5, 2017

Modernizing And Strengthening Existing Laws To Control Drug Costs

If President Trump truly intends to control drug costs, fixing drug pricing formulas and enhancing existing penalties could reduce costs for both public and private payers.

March 31, 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

A Better Balance Between Accelerated Access And High-Priced New Drugs: A New Conditional Approval Option

A new form of “conditional approval” could accelerate the approval of new drugs and, at the same time, take at least a small step towards reducing the costs of potentially life-saving drugs.

March 20, 2017

Manufacturers Of Biosimilar Drugs Sit Out The ‘Patent Dance’

The Biologics Price Competition and Innovation Act creates a pathway to approve biosimilars. However, biosimilar manufacturers' avoidance of this "patent dance" could be evidence of the increased reliance on trade secrets as a protection for intellectual property.

March 10, 2017

Can Employers Take A Bigger Role In Controlling Drug Costs?

Employees and employers alike continue to suffer from ‘sticker shock’ for prices for new drugs. While considerable attention has been paid to potential actions by Medicare or the FDA, there has been less focus on the role of private payers to solve the issue.

February 17, 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 Best-Laid Plans For Health Care

Tremendous uncertainty awaits, though I expect that we will see a slowing down of the repeal and replace process, with even the individual mandate persisting for some time; unmaking the Affordable Care Act without leaving millions stranded will be harder than the campaign may have suggested.

January 5, 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