James Boiani, an Associate in the Health Care and Life Sciences practice, in the Washington, DC, office, and Stuart Gerson, a Member of the Firm in the Health Care and Life Sciences and Litigation practices, in the Washington, DC, office, co-wrote an article titled "Missing the Point (Of Care): FDA Misreading of CLIA Waiver Law Undermines Cost-Effective Health Testing."
Following is an excerpt:
The United States Food and Drug Administration's ("FDA") misinterpretation of a single word in the statute establishing standards for granting so-called "CLIA Waivers" has created serious problems for patients and health-care providers alike by restricting access to important diagnostic tests. It is time to fix this problem and bring Americans the health care they deserve and at more reasonable cost.
The attached file is used with permission from the Washington Legal Foundation.
