1. Brief statement of the general nature of the views you wish to present.
On behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA), I am requesting one hour to present at the above public hearing. PhRMA represents America’s leading pharmaceutical and biotechnology companies who are collectively spending over $30 billion in research for new cures. The requested time will be allocated between several experts from PhRMA member companies who can respond to the issues that the Agency noted (67 Federal Register 18230).
PhRMA member companies have a longstanding commitment to exploring new avenues towards managing the risk of prescription drugs. The industry recognizes that while prescription drugs provide critical health benefits to American citizens, they are not without risks. Managing the benefits and risks of these products is a challenge to patients, physicians, the FDA and PhRMA companies. The clinical trial process is designed to evaluate the safety and efficacy of potential new therapies using the highest standards. It is recognized by all parties that all of the possible safety issues surrounding the widespread introduction of any new drug can never be fully established. Rare side effects or drug-drug interactions that occur once in every 10,000 or more patients are not routinely observed even in large clinical trials of 5000 -8000 patients. PhRMA member companies have established large pharmacovigilance divisions whose principal focus is to track and study safety issues once the drug is approved for marketing. This is done, not only to fulfill the FDA requirements to report significant adverse events post-market, but also because the industry wants to assure American patients that all possible safety issues are promptly identified and managed in an appropriate manner.
PhRMA has partnered with FDA and other external organizations to further develop new approaches towards risk management. Examples of these are:
1. PhRMA and FDA participation on the National Patient Safety Foundation, a group that is developing educational materials to better inform patients of the key factors they need to know as they take their medicines.
2. PhRMA and FDA participation on the National Coordinating Council on Medication Error Reporting and Prevention, a group that has issued recommendations on the use of bar codes to reduce medication errors in hospital settings.
3. PhRMA, along with FDA and the American Association for the Study of Liver Diseases, co-sponsored a two day workshop on hepatotoxicity. This meeting identified a series of potential research topics that will be useful in all phases of drug development from pre-clinical through to post-marketing activities.
4. PhRMA is continuing to work with FDA and the academic Centers for Excellence in Research and Therapeutics (CERTs) to sponsor a series of workshops in the areas of risk communication, risk assessment, benefit assessment and risk management. The first of these was held last June and the second is scheduled for this May.
5. PhRMA is working with pharmacy trade groups on a “paperless drug label” initiative that will enter the pilot phase this summer. PhRMA believes that the information presented in the present package insert can be delivered to pharmacies and other dispensing sites in an electronic format that will be more user friendly for all those who need up to date prescribing information. Secondly, the system will be amenable to virtually instant updating, so that these health care professionals will have access to important new safety information much faster.
PhRMA’s Safety, Epidemiology, and Post-Marketing Surveillance Task Group is in the process of preparing PhRMA’s response to the FDA for presentation at the public hearing. PhRMA plans not only to amplify on the above-mentioned activities but also provide reasoned comments on the questions that FDA posed in the Federal Register announcement. In addition, PhRMA will outline how the proposed risk management plan that is part of the PDUFA-III agreement provides a new tool that both FDA and industry can use in improving risk analysis and management.
PhRMA appreciates your consideration of our request.
2. The names and addresses of all persons who will participate in the presentation.
To Be Arranged. Our Safety Task Group is identifying the spokespeople.
3. Approximate time that you request to make your presentation.