NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.
The Time Has Come The idea of setting up a separate agency to oversee postmarketing surveillance has been proposed over the past two to three decades — perhaps now its time has come. I would endorse using a new source of user funds to establish a quasiautonomous agency separate from FDA and industry whose charge would be to act as a focus for drug safety issues. It should use various methods, ranging from having access to the numerous electronic claims and pharmacy databases available to designing specialized registries to assess drug use. It will only be successful if there is a large volume of input and the opportunity for fol low up with individual reporters. Using today’s technology, communications and recording of information must be easy, confi dential, and without risk of liability to the reporter. This is a tall order but now more pos sible with a combination of adequate funding and contemporary communications methods. John J. Schrogie, M.D. VP, PERIAPPROVAL RESEARCH SERVICES OMNICARE CLINICAL RESEARCH A Complicated Issue This is an immense and complicated issue. Generally, user fees paid by the industry are a good practical solution to delays in processing drug approvals. Faster approvals mean drugs get to market faster, saving lives and improv ing the quality of life. In the meantime, they might even lower the cost of branded drugs because they give the company a longer patent protected period to sell the drug. This gives them more time to recoup the cost of develop ment and marketing, thus improves the chances of plowing more money into drug development. In the perfect world, if the government would do this efficiently, never make a mis take, the costs of approval and regulatory com pliance would be lower. Postmarket issues are a very different issue. Sure, we all want good, timely data on the experience of drugs in the population. But, the FDA is just one source of these data. Clin ician experience and university research are great sources. If serious unanticipated side effects emerge, all parties should work togeth er as quickly as possible to get to the bottom of it; industry, clinicians, researchers, and gov ernment. And if possible, lawyers and courts should be the last resort. John Kamp OF COUNSEL WILEY REIN & FIELDING LLP The Yeahs Have It Yes, we support fees and a system where much of the generation and evaluation of safety data are done postlaunch. This would reduce the need (and the cost) of large Phase III trials, whose increasing size are driven by the desire to detect rare adverse events prelaunch. We believe in the ability of pharma com panies to be self policing. The benefits of this approach are many: patients will get faster access to lifesaving medications, and the costs of achieving our current level of safety will fall. Gerald R. Marschke DIRECTOR THE WEBSTER CONSULTING GROUP INC. Fair and Reasonable Yes, I think fair user fees are reasonable. Many other industries are expected to support the government agencies that oversee them — USDA and meat manufacturers, airlines and the FAA, etc. No, I don’t think user fees should be levied to create a new role for the FDA in after approval activities of any kind. Tracey Meyer CARDIOVASCULAR, DISTRICT SALES MANAGER ASTRAZENECA OPINIONS Is a new industry watchdog necessary?
In the January/February 2002 issue, PharmaVOICE asked readers if the Food and Drug Administration should collect special user fees from pharmaceutical manufacturers to analyze and disseminate data on new drugs and biologics after they are released into the general population.We wanted to know if postmarket surveillance should continue to be a function of the FDA, or should the industry become its own watchdog? On Equal Funding Although the FDA can certainly be overly bureaucratic and reactionary, I believe they play a critical, closertoimpartial role in the postmarketing surveillance of new drugs and biologics. How this activity is funded is a more com plex public policy quandary, but on the surface it would seem that funding should come from federally budgeted, taxbased resources, not incremental industry user fees. Matt Giegerich PRESIDENT AND CEO COMMONHEALTH Who Pays? Postmarketing surveillance is very important and beneficial. The questions are: who is going to do it and who is going to pay for it? To be done right, it needs to be funded at sufficient levels to provide continuity. So should it be funded privately, but conducted by the FDA? In today’s world there are so many drugs on the market that it would completely stretch the FDA’s resources. The last thing we need is another regulatory agency. I would vote to continue letting the industry self regulate. Rita Sweeney PRESIDENT AND CHIEF OPERATING OFFICER DORLAND SWEENEY JONES The Nays Have It “Nay” I say! The FDA should concentrate on speeding up drug approvals. The industry will be its own watchdog. Fear of litigation will keep it honest. Sandy Buck GROUP COPY SUPERVISOR, VP NCI ADVERTISING