healthy4u: Food and Drug Administration Safety and Innovation Act

Congress has just released an an Act "to amend the <a href="http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.htm" target="_blank">Federal Food, Drug, and Cosmetic (FD&C) Act</a> to revise and extend the user-fee programs for prescription drugs and medical devices, to establish userfee programs for generic drugs and biosimilars, and for other purposes."  Health IT provisions are included. This Act, S. 3187, is entitled the ‘‘Food and Drug Administration Safety and Innovation Act.’’  PDF fulltext is located at this link:  <a href="http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf">http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf</a> With regard to health IT, the Act states the following.  A risk-based regulatory framework pertaining to health IT is to be developed (emphases mine): <blockquote class="tr_bq"> <div align="left" style="font-family: Arial,Helvetica,sans-serif;">SEC. 618. HEALTH INFORMATION TECHNOLOGY.</div><div style="font-family: Arial,Helvetica,sans-serif;"></div><div align="left" style="font-family: Arial,Helvetica,sans-serif;"> </div> <div align="left" style="font-family: Arial,Helvetica,sans-serif;">(a) REPORT.—Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’), acting through the Commissioner of Food and Drugs, and in consultation with the National Coordinator for Health Information Technology and the Chairman of the Federal Communications Commission, shall post on the Internet Web sites of the Food and Drug Administration, the Federal Communications Commission, and the Office of the National Coordinator for Health Information Technology, a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.</div><div style="font-family: Arial,Helvetica,sans-serif;"></div><div style="font-family: Arial,Helvetica,sans-serif;"> </div> <div align="left" style="font-family: Arial,Helvetica,sans-serif;"> </div><div align="left" style="font-family: Arial,Helvetica,sans-serif;">(b) WORKING GROUP.—</div><div align="left" style="font-family: Arial,Helvetica,sans-serif;"> </div><div style="font-family: Arial,Helvetica,sans-serif;"></div><blockquote dir="ltr" style="margin-right: 0px;"><div style="font-family: Arial,Helvetica,sans-serif;"></div><div align="left" style="font-family: Arial,Helvetica,sans-serif;">(1) IN GENERAL.—In carrying out subsection (a), the Secretary may convene a working group of external stakeholders and experts to provide appropriate input on the strategy and recommendations required for the report under subsection (a).</div><div style="font-family: Arial,Helvetica,sans-serif;"></div><div style="font-family: Arial,Helvetica,sans-serif;"> </div> <div align="left" style="font-family: Arial,Helvetica,sans-serif;">(2) REPRESENTATIVES.—If the Secretary convenes the working group under paragraph (1), the Secretary, in consultation with the Commissioner of Food and Drugs, the National Coordinator for Health Information Technology, and the Chairman of the Federal Communications Commission, shall determine the number of representatives participating in the working group, and shall, to the extent practicable, ensure that the working group is geographically diverse and includes representatives of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small businesses, purchasers, employers, and other stakeholders with relevant expertise, as determined by the Secretary.</div> </blockquote></blockquote> While a welcome development, it is to be determined if the Working Group representatives will include critical thinkers without conflict of interest, whose contributions to the health IT debate in this country are needed a lot more than the traditional <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">hyper-enthusiasts</a>, industry courtiers and opportunists. I am actually not hopeful. The "promotes innovation" and "avoids regulatory duplication" phrases are of especially great concern.  As I've written before, "innovation" that involves non-consented experimentation is not innovation at all, it is exploitation, and "regulatory duplication" can become an excuse for milquetoast regulation by the conflicted (e.g., regulatory capture) or poorly qualified. I also note that this Act, while welcome, is long overdue - another example of putting the cart before the horse (<a href="http://hcrenewal.blogspot.com/2012/06/cart-before-horse-part-3-ahrqs-health.html" target="_blank">link</a>), with a national project (including CMS penalties for non-adopters) now several years underway. Final thought:  if health IT were safe as has been claimed now for decades, or had been made safe through proper development and clinical trials-based testing, we would not need health IT provisions in a  "Food and Drug Administration Safety and Innovation Act" in 2012. -- SS

FDA Safety and Innovation Act: To contain an "Appropriate, risk-based regulatory framework pertaining to health information technology"

Congress has just released an an Act "to amend the Federal Food, Drug, and Cosmetic (FD&C) Act to revise and extend the user-fee p...

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