Medical Device Safety versus Corporate Profits

Public Citizen’s work on the Food and Drug Administration Safety and Innovation Act (FDASIA)

The news is full of stories of malfunctioning devices and dangerous drugs that injure or kill patients and are on the market because of a lax approval process. Reports to the government of device-related injuries and deaths are up dramatically. In 2012, Congress considered sweeping changes to the way the industry was overseen, as part of a process that occurs every five years to reauthorize user fees that the drug and device makers pay the Food and Drug Administration to review their products for the market. But instead of considering improvements to device and drug safety, lawmakers endorsed industry-backed changes that risked more dangerous devices and drugs being given to patients, and therefore, more injuries and deaths. Public Citizen fought successfully to remove some of the worst provisions from the legislation, which was signed into law as the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012.

Learn more about our work related to FDASIA

• Press Release: House and Senate Negotiators Agree on Final Legislation That Would Weaken Medical Device and Drug Safety, June 19, 2012
• Statement: Congress Should Remove or Narrow Provision That Would Restrict Public Access to Important Health and Safety Information, May 29, 2012
• Letter Urging Senators to Oppose Senator Coburn’s Amendment Creating Perverse Incentives for Speedier Reviews by FDA Scientific Reviewers, May 24, 2012
• Letter Urging Senators to Oppose Senator Burr’s Amendment Politicizing FDA-Industry Use-Fee Negotiations, May 24, 2012
• Statement and Letter from Public Citizen Supporting Sen. Bernie Sanders’ Amendment Holding Pharmaceutical Companies Accountable for Fraud, May 22, 2012
• Statement of Dr. Michael Carome on Key House Committee to Vote on Legislation That Would Weaken Medical Device and Prescription Drug Regulations, May 10, 2012
• Letter to House Energy and Commerce Committee Expressing Serious Concerns Regarding Legislation Renewing FDA User-Fee Programs, May 9, 2012
• Medical Device Industry at a Crossroads: Will Industry Profits Trump Patient Safety?, May 7, 2012
• Letter of support for Senator Sanders’ PDUFA amendment on pharmaceutical fraud, April 24, 2012
• Letter of support for Senator Sanders’ PDUFA amendment on pharmaceutical fraud, April 24, 2012
• Letter to Senate HELP Committee Expressing Serious Concerns Regarding the Proposed Food and Drug Administration Safety and Innovation Act, April 24, 2012
• Letter to Senate HELP Committee Opposing the PATIENTS’ FDA Act, April 23, 2012
• Letter to the House Subcommittee on Health of the Committee on Energy and Commerce Opposing Legislation Proposing to Amend the Food, Drug and Cosmetic Act, April 17, 2012
• Letter to the Senate HELP Committee Opposing Draft Legislation Proposing Incentives for Antibiotic Development, April 9, 2012
• Recommendations on the Senate HELP Committee Draft Medical Device Bill, April 2, 2012
• Substantially Unsafe: Medical Devices Pose Great Threat to Patients; Safeguards Must be Strengthened, Not Weakened, February 15, 2012
• Statement to the Subcommittee on Health of the House Energy and Commerce Committee Advocating for Legislation to Improve Medical Device Safety, February 15, 2012
• Letter Opposing Senate Bill S. 1700, November 1, 2011