Transcript Slides
PDUFA: A Consumer & Patient Perspective Sally Greenberg Executive Director National Consumers League Consumer versus Patient • Weigh risks differently – Patients: less emphasis on risks with new drug – Consumer: risk-benefit calculus PDUFA should provide “timely access to safe and effective drugs while reducing exposure to harmful medications that pose undue risk” FDA Performance According to a 2012 United States GAO report: 1. FDA met most of its performance goals thanks to funding authorized by PDUFA 2. PDUFA enabled the FDA to collect user fees of more than $529 million 3. FDA completed over 1,400 review actions and met or exceeded the majority of its performance goals for FY14 Performance Goals • Purpose: protect patients from risks of drugs • PDUFA needs adequate safeguards • One of the most significant safeguards: FDA’s ability to deny approval or require sponsors demonstrate “substantial evidence” of drug’s effectiveness NCL Stance on Off-Label Use • Off-label use is using pharmaceutical drugs for unapproved indication, dosage, or administration. • NCL concerns: – Ensuring medications used in safe and appropriate manner – Ensuring consumer is informed that the medication prescribed is for another condition and knows risks and benefits Off-Label Use 2006 study found high rates of off-label use with little or no scientific support A Wall Street Journal poll found that nearly half of Americans thought medication could only be prescribed for an approved condition Off-Label Use Consumers should be informed about the following IF they are prescribed drugs offlabel: 1. 2. 3. 4. 5. Availability of indicated alternatives Body of evidence supporting product use Special population considerations Approval status/use in other countries Implications for insurance coverage Direct to Consumers (DTC) Advertising 4.5 billion dollars spent on direct to consumer adverting of prescription drugs in 2014 Over 91% of Americans said they have seen or heard advertisements for prescription drugs Direct to Consumers (DTC) Advertising Only 33% of prescription and nonprescription drug ads were objectively true 57% of prescription and non prescription drug ads were potentially misleading 10% of prescription and non prescription drug ads were false DTC Advertising Solutions User fees be allocated to hire more staff 1. Review ads 2. Respond to industry feedback in a timely manner Thank you!