Tuesday, October 18, 2011

The Rhetoric Doesn't Match

Congresswoman McMorris Rodgers announced that she and several other Republican congressmen have introduced the Keeping America Competitive through Harmonization Act.

“While America has led the medical device industry for decades, our leadership is being threatened by the FDA’s unpredictable, inconsistent and inefficient regulation of medical devices,” said Rep. McMorris Rodgers. “According to job creators I’ve met, harmonizing FDA requirements with those of foreign regulators would help improve FDA regulation, expedite approval of life-saving and life-improving treatments, and improve the environment for job creation. Our bill will charge the FDA with undertaking the common-sense reforms that are needed to keep America the world capital of medical innovation.”

I thought I'd check out this landmark proposed legislation. It amends Section 803(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 383(c)). The entire bill is almost as long as the title so I'm including the full text.

    (a) In General- Paragraph (4) of section 803(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 383(c)) is amended to read as follows:

    (4) With respect to devices, the Secretary shall, to the maximum extent practicable, enter into agreements with those countries identified in clauses (i) and (ii) of section 802(b)(1)(A) regarding methods and approaches to harmonizing regulatory requirements for premarket review, inspections, and common international labeling symbols.'.

    (b) Report - Not later than 3 years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report listing the agreements entered into under section 803(c)(4) of the Federal Food, Drug, and Cosmetic Act (as amended by subsection (a)) and itemizing the methods and approaches that have been harmonized pursuant to such section.

If you're into that kind of stuff you can read Section 802 and Section 803. They're pretty short so go ahead and take a look.

Note that "harmonizing regulatory requirements" doesn't necessarily mean shorten or lengthen the time it takes to approve a medical device. And "the maximum extent practicable" is hardly a mandate.

Here's what I'm not clear on and I'll explain it with a hypothetical situation. Let's say the FDA is evaluating Device A and it will take five years to complete the evaluation. The EU is evaluating a similar device and it will take eight years to complete. South Africa has evaluated Device A for the past year and expects to complete it in one year. We conclude an agreement with South Africa that harmonizes the regulatory requirements for medical devices. (I'm not sure if that's possible because there are medical devices and then there are medical devices.)

Let's say the agreement includes Device A and now the evaluation period is two years. Does the FDA start afresh with the newly agreed upon regulation or wait for South Africa to complete the process and use that as the basis for approval? Now let's say the agreement was made with the EU instead and the new requirement is a eight year process. Will the medical manufacturers scream WTF?

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