Several bills to extend the user-fee programs for prescription drugs and medical devices and to establish user-fees for generic drugs and biosimilars are making rounds in the Senate and House this week. But the version in the House comes with an added surprise, reports Med Page Today.
The FDA currently collects user fees from brand-name drug and medical device companies in order to pay for the review of applications for new drugs and medical devices — the current legislation establishing user fees expires Sept. 30.
Author of the user-fee House bill, Rep. Mike Rogers (R-Mich.), goes a step further than extending user-fees and adding new ones for generics. He rewrites part of the mission statement of the FDA, saying the agency should "protect the public health and enable patients to access novel products while promoting economic growth, innovation, competitiveness, and job creation among the industries regulated by this Act."
According to its website, the FDA is "responsible for protecting the public health by assuring the safety, efficacy and security" of drugs, medical products, cosmetics and the food supply and "advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable."
Nowhere does the FDA's mission mention "promoting economic growth, innovation, competitiveness and job creation."
Advocacy group the Consumers Union — the policy arm of Consumer Reports — is up-in-arms about the House and Senate user-fee bills moving, saying they ease too many restrictions in the name of business and fail to address the needs of consumers. "Neither bill includes critical reforms needed to protect patients from dangerous or defective devices," the Consumers Union writes in a statement about the pending legislation.
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The FDA currently collects user fees from brand-name drug and medical device companies in order to pay for the review of applications for new drugs and medical devices — the current legislation establishing user fees expires Sept. 30.
Author of the user-fee House bill, Rep. Mike Rogers (R-Mich.), goes a step further than extending user-fees and adding new ones for generics. He rewrites part of the mission statement of the FDA, saying the agency should "protect the public health and enable patients to access novel products while promoting economic growth, innovation, competitiveness, and job creation among the industries regulated by this Act."
According to its website, the FDA is "responsible for protecting the public health by assuring the safety, efficacy and security" of drugs, medical products, cosmetics and the food supply and "advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable."
Nowhere does the FDA's mission mention "promoting economic growth, innovation, competitiveness and job creation."
Advocacy group the Consumers Union — the policy arm of Consumer Reports — is up-in-arms about the House and Senate user-fee bills moving, saying they ease too many restrictions in the name of business and fail to address the needs of consumers. "Neither bill includes critical reforms needed to protect patients from dangerous or defective devices," the Consumers Union writes in a statement about the pending legislation.
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Sen. Al Franken: U.S. Does Not Have to Choose Between Patient Safety, Device InnovationFDA Takes Steps to Foster Judicious Antimicrobial Use
Summary of FDA's Proposed Changes to Cleaning Requirements for Biological Products