The FDA has a news article on their website related to a bill that will be introduced this week.
A bill establishing a comparative-effectiveness research institute is scheduled for introduction in the Senate this week, congressional staffers say.
The Comparative Effectiveness Research Act of 2008, sponsored by Sens. Kent Conrad (D-N.D.) and Max Baucus (D-Mont.), would establish an institute to evaluate the effectiveness of different drugs and medical devices that exist for the same treatment.
The creation of such an organization was the subject of a public meeting held last week by the Medicare Payment Advisory Commission (MedPAC), an independent agency that advises Congress on issues affecting Medicare. The group supports a comparative-effectiveness program and recommends that Congress establish an independent entity to sponsor and disseminate such information. The entity would conduct prospective, head-to-head clinical trials of competing products as well as clinical reviews.
In a report last June, MedPAC said not enough credible, empirically based information is available for providers and payers to make decisions on alternative treatments and diagnostics for the most common conditions. New services become routine medical care without their comparative effectiveness being taken into account, the commission said.
Recently, Centers for Medicare & Medicaid Services’ Chief Medical Officer Barry Straube said Medicare would have to address comparative-effectiveness and cost-effectiveness issues to achieve greater value for the program. MedPAC agreed. One committee member said the research needed today is not to support another device or “me-too drug” but to promote value. The commission also advised that the institute have no role in making or recommending coverage or payment decisions.
It is a controversial topic and all sides need to be considered.
It is important that patients have information that compares various treatments for their decision making process.
At the same time we do not want decisions made for patients based on cost.
We also want to be sure that Quality of Life issues are considered in decision making.
I have included some links that will give you some background information on comparative effectiveness research.