"THE HEART OF THE MATTER"
a special program of the National Emergency Medicine Association (NEMA)


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Week: 597.6 Pt. 1 

Guests: Rep. Tom Bliley, D.VA Chairman, House Commerce Committee, Sen. Edward Kennedy, D. MA, Shelby Oppenheimer, ALS sufferer, Jeff Truitt, pharmaceutical industry spokesman

Topic: FDA reform passes 

Reporter: Aaron Cohen 

Host/Producer: Steve Girard 

NEMA: Red tape has been a hallmark of the Food and Drug Administration, and the agency has been a favorite target for Capitol Hill critics bearing long knives for wasteful government departments. But the FDA instituted some long overdue changes to get drugs and medical devices to doctors and patients faster, motivating Congress to make moves to reform the agency....Aaron Cohen has Health on the Hill.... 

COHEN: House Commerce Committee Chairman Tom Bliley joked to reporters that if you had told him modernization of the Food and Drug Administration would pass the House without a fight, he would have said you were on drugs. And he doesn't mean the latest treatment for osteoporosis. But the sweeping reform quickly passed the Senate and then the House...and Bliley says the consequences may reach right into your medicine cabinet... 

BLILEY: Patients will get medicines faster, medical devices will get to the people who need them, and the FDA will be more efficient. It shows what people can do if they put the country first. 

COHEN: The engine driving reform of the FDA is the expiring Prescription drug user fee act. At one time, the FDA was so entwined with red tape that a promising new medicine would take years to reach the market. So, drug manufacturers pooled their resources, and kicked in 327 million dollars over 5 years, to hire 600 drug reviewers at the FDA. Their job is to accept or reject new compounds quickly. And the remarkable thing is that it worked. New drugs are now available for patients made their way through the bureaucratic maze...in record time. that's why industry spokesman Jeff Truitt says drug companies put on the full court press to reauthorize the program, which expired October 1st... 

TRUITT: it's a very, very good investment. it's a win-win situation for everybody involved. it's good for the companies...they get on the market faster. it's good for patients who are getting new medicines faster. it's good for FDA because it's extra money that they desperately needed.  

COHEN: One patient who will be happy to see the FDA bureaucracy streamlined is Shelby Oppenheimer. At 30, Oppenheimer is prevented by FDA rules from obtaining an experimental drug called myotrophen, to treat the pain associated with her Lou Gehrig's Disease. The Pennsylvania woman is in the early stages of the nerve disorder, and believes from studies that the drug won't do her any harm. But until the president signs the FDA bill, Oppenheimer won't know if it will do her any good... 

OPPENHEIMER: ...the drug I'm interested in taking has shown promise that it can slow the progression in early stages of the disease...giving you longer quality of life. You can brush your own teeth longer...you can say "I love you" to someone a little bit longer... 

COHEN: While reauthorizing the Prescription drug user fee act for another 5 years, and allowing seriously ill patients like Shelby Oppenheimer access to experimental drugs, was relatively free of controversy...FDA reform was never a sure thing. In the Senate, Massachusetts Democrat Ted Kennedy almost single handedly held passage of the bill hostage...for weeks. Kennedy had many objections, but one that particularly sticks in his craw - that the FDA can only test the "announced" use of a medical device before it is approved. The example Kennedy frequently gave during floor debate was the biopsy needle... 

KENNEDY: It can in under one particular label, and was being promoted and marketed for an entirely different purpose: and that was removing tumors from women's breasts. And there was absolutely no information submitted as to whether that was a safe procedure, or was not.. Maybe it was, maybe it wasn't. But the public, the woman, who's having that particular procedure ought to at least have assurance that that process and procedure is as safe as possible, and under the language that was accepted in the Senate, they would not have that today. And that is basically the issue. 

COHEN: Despite Kennedy's objections, the FDA will continue getting help from outside the agency in approving medical devices. Universities and private labs will help review devices like hearing aids, but the Food and Drug Administration would still have the last word. The Clinton administration supports the FDA modernization bill, but would like to tweak it...every so slightly. Shelby Oppenheimer just wants them to get on with it, so that she can get the drugs she needs... 

OPPENHEIMER: And then there are people like me who are not on the drugs, who are saying, "I'm a young woman, I have a bright future. Let me try this drug and see if it can help buy me time until there is a cure".  

COHEN: For Health on the Hill, I'm Aaron Cohen.  

NEMA: Thanks Aaron...catch Health on the Hill each week on the Heart of the Matter Some stories we have coming up for you...Research shows that health care workers may be spreading the flu viruses that kill tens of thousands of nursing home residents each year...but only a quarter of them get yearly flu shots...Irradiated cancer cells are being injected into tumors...carrying a virus that may help physicians destroy cancer without surgery, and without systemic side effects...

So stay with us for more interesting health and medicine stories. 

SPOT: Small pages....big advice on parenting...from infants to teens. What to expect, emotionally and physically, as your child grows. How to develop positive discipline, how to deal with kids and TV, adolescent issues, drug education, fighting, single and step parenting...it's all in the Little Book of Parenting, available through the National Emergency Medicine Association. Call 1-800-332-6362 for more information. 

NEMA: Thanks for joining us for today's program. If you have any comments or suggestions, contact this station. Or visit our home page at: www.nemahealth.org/...for a look at transcripts of this or past programs, or to find out more about the National Emergency Medicine Association. I'm Steve Girard at The Heart of the Matter.