Orphan Diseases Or Population Health? Policy Choices Drive Venture Capital Investments

The surge in orphan drugs is a result of public policies that influence development costs and market exclusivity, which in turn influence the prices that can be charged. The policy decisions made yesterday influence investment decisions made today, and hence the direction of innovation tomorrow.

July 21, 2017

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

At Drug Hearing, Senators Discuss Meanings Of Price And Value—And Debate Health Reform

On Tuesday, June 13, the Senate HELP Committee held the first of three planned hearings on high drug prices. One of the most important points to come out of the hearing was that there is bipartisan concern about high drug prices, even if there is as yet little agreement on what to do about them.

June 20, 2017

Sandoz v. Amgen: What The Court Settled, What It Didn’t, And What Might Come Next

On June 12, the Supreme Court ruled that biosimilar companies will generally be able to launch their product as soon as the data exclusivity on the innovative product expires. In simple terms, this translates to cheaper medicines sooner. On a second issue, the outcome was more complex.

June 19, 2017

Follow The Money: The Flow Of Funds In The Pharmaceutical Distribution System

Publicly traded companies in the pharmaceutical distribution system must disclose annual financial information to the SEC. Those reports provide some of the most reliable public information about how funds flow through the distribution system.

June 13, 2017

Debunking The Pharmaceutical Research ‘Free Rider’ Myth: A response To Yu, Helms, And Bach

The claim that “everyone gets a free ride off us,” pushed by pharmaceutical companies to the US public and policy makers, is simply not true. It has been made so often for so long that many hold it as an economic fact, even though no solid evidence is presented to back it up.

June 2, 2017

Drug Prices And Medical Innovation: A Response To Yu, Helms, and Bach

If US policy makers were to enact regulations that drive prices down significantly, many projects that now have positive expected returns would no longer be profitable. Current prices would be lower but so would the expected level of future innovation.

June 2, 2017

Pharmaceutical Product Hopping: A Proposed Framework For Antitrust Analysis

Not all reformulations pose competitive concerns. But a dangerous subset of such reformulations is undertaken for one, and only one, reason: to delay generic entry. In such cases, reformulation is called “product hopping.”

June 1, 2017

Mandating Coverage Of Abuse-Deterrent Opioids Would Be A Costly Distraction From More Effective Solutions

It is tempting to see abuse-deterrent opioids as a powerful and singular solution that might go a long way toward addressing our nation’s opioid crisis. But, it is not so simple.

May 26, 2017

Measuring Value Based On What Matters To Patients: A New Value Assessment Framework

Despite the drive toward value-based health care reimbursement and patients’ ever increasing financial stake in their own health care treatment, many traditional value assessment tools fail to consider value from the patient’s perspective.

May 23, 2017