Here are five recently introduced pieces of legislation that affect the medical device industry.
The FDA Mission Reform Act
Introduced by: Sen. Dan Coats (R-Ind.)
Date: Dec. 8, 2011
Cosponsors: Sen. Kelly Ayotte (R-N.H.)
The bill aims to clarify and reform the mission of the FDA to promote job creation. It would require the FDA to establish a predictable, consistent and transparent regulatory environment and add language to the FDA's mission statement that would allow the agency to advance medical innovation by incorporating modern scientific tools, standards, and approaches; protect public health and enable patients to access novel products while promoting economic growth, innovation, competitiveness and job creation; indentify and use the most innovative and least burdensome tools and incorporate a patient-focused benefit-risk framework.
"The current regulatory environment created by the FDA has forced American companies to eliminate jobs and move operations overseas," Sen. Coats said in a release. "Unpredictable and burdensome regulations from this agency have severely impacted medical device manufacturing, an important industry in Indiana's economy. These are tough economic times, and we need to support, not punish, our job creators so they can innovate and expand."
Novel Device Regulatory Relief Act of 2011
Introduced by: Sen. Scott Brown (R-Mass.)
Date: Dec. 5, 2011
Cosponsors: Sen. Kelly Ayotte (R-N.H.)
The bill would amend section 513 of the Federal Food, Drug, and Cosmetic Act to speed up the process for requesting 'de novo' classification of a device. The FDA currently allows companies to apply for 'de novo' status if the device represents an improvement on an already approved device rather than being a completely new device. The bill would allow devices that pose low or moderate safety risks but have no previously approved precedent to apply for 'de novo' status without a 510(k) application. The bill clarifies language in a similar bill filed earlier this year in the House by Rep. Brian Bilbray (R-Calif.).
MODDERN Cures Act of 2011
Introduced by: Rep. Leonard Lance (R-N.J.)
Date: Nov. 18, 2011
Cosponsors: Reps. Barney Frank (D-Mass.), Randy Hultgren (R-Ill.), Jay Inslee (D-Wash.), Thomas Latham (R-Iowa) and Joe Walsh (R-Ill.)
This bill would grant specific periods of patent exclusivity for drug and diagnostic test makers when they collaborate on companion diagnostics as well as establish the Advanced Diagnostics Education Council under the jurisdiction of Health and Human Services. The council would establish standard terms and definitions of diagnostic testing. The bill would also alter the Medicare reimbursement fee schedule for diagnostics. The bill also goes by the longer name of the Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2011.
Patient Access to Medical Innovation Act
Introduced by: Sen. Al Franken (D-Minn.)
Date: Nov. 15, 2011
Cosponsors: Lamar Alexander (R-Tenn.), Kay Hagan (D-N.C.) and John Kerry (D-Mass.)
Currently, device makers that sell products with humanitarian exemptions are prohibited from selling the device for more than the cost of research and development, fabrication and distribution unless it's intended for a pediatric market. This bill would allow manufacturers of products that have been granted a humanitarian exemption to profit from development of those devices whether they're used in pediatric or adult populations. A device can be given a humanitarian exemption if it diagnoses or treats diseases and conditions affecting fewer than 4,000 Americans per year, would not be available unless the FDA granted the exemption and the device's probable benefit outweighs the risk. The bill also proposes to make this change retroactive, so companies who are currently selling a device with a humanitarian exemption would be able to sell the device for a profit after the bill's passage.
The bill would also ease the conflict of interest restrictions on FDA advisory committee members. The bill would require the FDA to consider the "scope and magnitude of the financial interest at issue with the public health need" when excluding experts from advisory panels based on conflicts of interest. The conflict of interest restrictions have been blamed for barring industry experts from serving on panels.
Medical Device Regulatory Improvement Act
Introduced by: Sen. Amy Klobuchar (D-Minn.)
Date: Oct. 13, 2011
Cosponsors: Michael Bennet (D-Col.) and Richard Burr (R-N.C.)
This bill would amend the "least burdensome" and "conflicts of interest" provisions in sections 513 and 712 of the Federal Food, Drug, and Cosmetic Act. The amendments to section 513 are intended to lessen the scientific burden on manufacturers during the premarket approval process. The bill would require the FDA to reduce review times by considering alternatives to randomized, controlled clinical trials whenever possible in both the premarket approval and the 510(k) processes. The amendment to section 712 would provide for a comprehensive review of the management and operations of the FDA's Center for Devices & Radiological Health by an experienced organization. The organization would be required to submit its findings and recommendations to Congress within one year.
Related Articles on Medical Devices:
FDA, CDC and AAO to Monitor Cataract Surgery Devices to Stop TASS Outbreaks
Medical Device Industry Spent Almost $32M Lobbying Congress in Third Quarter
FDA Proposes Draft Guidelines to Improve the Representation of Women in Medical Device Clinical Studies
The FDA Mission Reform Act
Introduced by: Sen. Dan Coats (R-Ind.)
Date: Dec. 8, 2011
Cosponsors: Sen. Kelly Ayotte (R-N.H.)
The bill aims to clarify and reform the mission of the FDA to promote job creation. It would require the FDA to establish a predictable, consistent and transparent regulatory environment and add language to the FDA's mission statement that would allow the agency to advance medical innovation by incorporating modern scientific tools, standards, and approaches; protect public health and enable patients to access novel products while promoting economic growth, innovation, competitiveness and job creation; indentify and use the most innovative and least burdensome tools and incorporate a patient-focused benefit-risk framework.
"The current regulatory environment created by the FDA has forced American companies to eliminate jobs and move operations overseas," Sen. Coats said in a release. "Unpredictable and burdensome regulations from this agency have severely impacted medical device manufacturing, an important industry in Indiana's economy. These are tough economic times, and we need to support, not punish, our job creators so they can innovate and expand."
Novel Device Regulatory Relief Act of 2011
Introduced by: Sen. Scott Brown (R-Mass.)
Date: Dec. 5, 2011
Cosponsors: Sen. Kelly Ayotte (R-N.H.)
The bill would amend section 513 of the Federal Food, Drug, and Cosmetic Act to speed up the process for requesting 'de novo' classification of a device. The FDA currently allows companies to apply for 'de novo' status if the device represents an improvement on an already approved device rather than being a completely new device. The bill would allow devices that pose low or moderate safety risks but have no previously approved precedent to apply for 'de novo' status without a 510(k) application. The bill clarifies language in a similar bill filed earlier this year in the House by Rep. Brian Bilbray (R-Calif.).
MODDERN Cures Act of 2011
Introduced by: Rep. Leonard Lance (R-N.J.)
Date: Nov. 18, 2011
Cosponsors: Reps. Barney Frank (D-Mass.), Randy Hultgren (R-Ill.), Jay Inslee (D-Wash.), Thomas Latham (R-Iowa) and Joe Walsh (R-Ill.)
This bill would grant specific periods of patent exclusivity for drug and diagnostic test makers when they collaborate on companion diagnostics as well as establish the Advanced Diagnostics Education Council under the jurisdiction of Health and Human Services. The council would establish standard terms and definitions of diagnostic testing. The bill would also alter the Medicare reimbursement fee schedule for diagnostics. The bill also goes by the longer name of the Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2011.
Patient Access to Medical Innovation Act
Introduced by: Sen. Al Franken (D-Minn.)
Date: Nov. 15, 2011
Cosponsors: Lamar Alexander (R-Tenn.), Kay Hagan (D-N.C.) and John Kerry (D-Mass.)
Currently, device makers that sell products with humanitarian exemptions are prohibited from selling the device for more than the cost of research and development, fabrication and distribution unless it's intended for a pediatric market. This bill would allow manufacturers of products that have been granted a humanitarian exemption to profit from development of those devices whether they're used in pediatric or adult populations. A device can be given a humanitarian exemption if it diagnoses or treats diseases and conditions affecting fewer than 4,000 Americans per year, would not be available unless the FDA granted the exemption and the device's probable benefit outweighs the risk. The bill also proposes to make this change retroactive, so companies who are currently selling a device with a humanitarian exemption would be able to sell the device for a profit after the bill's passage.
The bill would also ease the conflict of interest restrictions on FDA advisory committee members. The bill would require the FDA to consider the "scope and magnitude of the financial interest at issue with the public health need" when excluding experts from advisory panels based on conflicts of interest. The conflict of interest restrictions have been blamed for barring industry experts from serving on panels.
Medical Device Regulatory Improvement Act
Introduced by: Sen. Amy Klobuchar (D-Minn.)
Date: Oct. 13, 2011
Cosponsors: Michael Bennet (D-Col.) and Richard Burr (R-N.C.)
This bill would amend the "least burdensome" and "conflicts of interest" provisions in sections 513 and 712 of the Federal Food, Drug, and Cosmetic Act. The amendments to section 513 are intended to lessen the scientific burden on manufacturers during the premarket approval process. The bill would require the FDA to reduce review times by considering alternatives to randomized, controlled clinical trials whenever possible in both the premarket approval and the 510(k) processes. The amendment to section 712 would provide for a comprehensive review of the management and operations of the FDA's Center for Devices & Radiological Health by an experienced organization. The organization would be required to submit its findings and recommendations to Congress within one year.
Related Articles on Medical Devices:
FDA, CDC and AAO to Monitor Cataract Surgery Devices to Stop TASS Outbreaks
Medical Device Industry Spent Almost $32M Lobbying Congress in Third Quarter
FDA Proposes Draft Guidelines to Improve the Representation of Women in Medical Device Clinical Studies