Let Congress Know that Devices Are Different
For the first time in 12 years, the Democrats are in control of Congress. This means that the pharmaceutical industry, one of the ousted Republican leadership's biggest allies, is on the outs. Politicians, the press, and the public often assume the device industry wants the same things as the drug industry and that it should be treated the same way. That has never been the case, and now is an especially good time to make that known. Reform of the drug industry and the way FDA regulates it is at the top of the Democrats' to-do list. The device industry must make sure that it doesn't get swept up in the tide of change.
A January 3, 2007, article by Bloomberg News speaks of "a Congress controlled by Democrats determined to impose costly restrictions on [the pharmaceutical industry]."
"Five committees are planning investigations into how to lower prices paid by Medicare, improve drug-safety enforcement, and make generic medications available faster," it states. "Further probes and policy salvos may follow."
Will the device industry feel similar wrath? There
is hope that it won't. As it happens, one of the article's
authors, Kristin Jensen, is a friend of mine from college.
I asked her whether the Democrats plan to come down
on the device industry, too. "Nobody
really mentions devices when they talk about the lopsided
giving, etc.," she
says. "Their trade groups are traditionally much more quiet than [those
of the pharmaceutical and biotechnology industries]
in terms of stuff happening on the Hill."
It will be very important for the device industry to be perceived separately and distinctly from the other life sciences industries. The industry is different in structure, in product life cycles, and in methods of development, among other ways. Grafting reforms designed for pharmaceuticals and biotechnology onto devices would do a great disservice to firms, caregivers, and patients.
The stakes are high because fundamental questions about CDRH's funding will be asked this year as part of the reauthorization of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).
One of the problems with the original MDUFMA is that
Congress, then under Republican control, failed to
come up with all of the increased funding for the CDRH budget that it
had promised. Although Democrats are not considered to be as industry-friendly
as their Republican counterparts, here is one case where they might be
in a better position to help industry. Traditionally Democrats have been
more willing to spend for domestic programs than have Republicans. Perhaps,
then, the new Democratic-controlled Congress may be willing to fund the
CDRH budget at a higher level than its Republican-controlled predecessor
was.
Thus, by sending the appropriate message to the Democrats, not only might the device industry avoid punitive reforms, but also it might be able to get Congress to commit to bolstering FDA's medical device program.
Erik Swain
erik.swain@cancom.com
Materials
Using Acrylic to Lower Costs and Make Smaller Devices
By Peter Colburn and Holger Tinz
Prudent materials selection can help device makers reduce the cost of manufacturing small devices.
Molding
Multishot Makes Inroads in Medical Molding
By William Leventon
In appropriate applications, multishot molding can streamline production and improve product quality.
Packaging
Consider the Basics when Developing Packaging
By Randall Troutman
Package designers must understand the device, the packaging material, and all the end-user requirements before achieving a successful package.
Drug and Device Combinations
Combination Medical Products: Capitalizing on Convergence
By Chris Cramer and Sharad Rastogi
Manufacturers that can master the technical, regulatory,
and business challenges associated with combination products will be ahead
of the pack.
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