Letter to Secretary Sebelius on Proposed Recommendations for PDUFA V

The coalition’s main concern is that most of the recommendations are aimed at industry perceived barriers to new drug approvals, rather than concerns about protecting and promoting the health of patients and consumers by ensuring timely access to safe and effective drugs. They recognize that some of the recommendations have the potential to benefit patients by speeding up the approval process and improving the chances that drugs will be available when they are needed. There is too little emphasis, however, on performance goals aimed at improving the safety and efficacy of drugs. The focus must be on a process that provides timely access to safe and effective drugs while reducing exposure to harmful drugs that pose undue risks. Drugs must only be approved with adequate evidence to support their safety and effectiveness and a robust post-market surveillance system must be in place to ensure that drugs found to be dangerous are removed from the market as quickly as possible.

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