Tag Archives: generic drugs

A Billion Here, A Billion There: Selectively Disclosing Actual Generic Drug Prices Would Save Real Money

Selectively disclosing de-identified information on generic ingredient costs would enable health plans to negotiate reduced reimbursements to retail pharmacies for generic drugs.

September 12, 2017

FDA User Fee Reauthorization Clears Hurdle In Senate With Bipartisan Support

On May 11, the Senate Committee on Health, Education, Labor and Pensions marked up the proposed FDA user fee reauthorization bill and voted 21-2 to advance it to the full Senate. The bill would reauthorize the fee system for FDA approval of drugs, medical devices, generic drugs, and biosimilars.

May 15, 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

Unpacking Drug Price Spikes: Generics

The generics market has been in turmoil---shortages, price spikes, quality issues, compounding abuses---since 2008. What can be done to create a healthy marketplace?

March 21, 2016

Addressing Generic Drug Unaffordability And Shortages By Globalizing The Market For Old Drugs

Meaningful intellectual property ownership for older medications expired decades ago, and they are now subject to massive price increases or severe shortages. This need not be the case, and there are remedies to address these problems.

February 23, 2016

Six Big Trends To Watch In Health Care For 2016

With the upcoming Presidential election, health care is once again keeping us up at night. How much of the current debate is hyperbolic rhetoric? What policy changes are realistic in an election year? What market trends in the private sector will drive the most change?

December 30, 2015

Implementation Of The Biosimilars Provisions Of The ACA — Where Are We Now?

The FDA's approval this year of the first biosimilar has prompted a flurry of regulatory activity. Key concerns raised by recent FDA guidance remain, as well as other widely anticipated but yet-to-be released regulatory activity, such as the pivotal interchangeability standard.

December 14, 2015

Prescription Drugs And The Slowdown In Health Care Spending

Several studies have examined the underlying sources for the recent slowdown in health care spending. However, they do not account for the full decline in spending, or raise questions about the pattern and timing of the slowdown.

November 18, 2015

How Government Policy Promotes High Drug Prices

US law governing prescription pharmaceutical markets gives every new drug a long-term monopoly that prohibits competition. High prices and slow innovation cycles are the inevitable result and will remain so unless Congress makes fundamental changes in existing law.

October 29, 2015

Who Makes This Drug? Disclosing The Identity Of Generic Drug Manufacturers

Counting and identifying manufacturers able to supply the U.S. with generic drugs or their base ingredients is critical for promoting public health goals, yet the number and identity of these manufacturers is shrouded from public oversight. We recommend three measures that the U.S. Congress...

October 16, 2015