By Kim Coghill
WASHINGTON - Biotechnology insiders say a bill passed in the House Wednesday that permits pharmacies and wholesalers to purchase reimported drugs does little if anything to save money for consumers.
The measure, which is part of the Agriculture Appropriations bill, is scheduled for a vote in the Senate early next week.
If passed and signed by President Bill Clinton, it will direct the FDA to implement a regulatory program to monitor United States borders and test reimported drugs for safety and counterfeiting. The provision includes $23 million for the first year of development and implementation. Beyond that, the FDA said the program will cost about $93 million annually to operate.
Rep. Marion Berry (D-Ark.) said assigning the FDA to monitor the program will ensure the safety of drugs. "We have people now going to Canada or Mexico every day to buy drugs and there is no guarantee they are getting what they think they are getting."
He said there is very little supervision of reimported drugs currently, and Americans are obviously going to turn to international markets for prescription drugs because of the escalating costs here.
But Mark Skaletsky, president and CEO of Waltham, Mass.-based GelTex Pharmaceuticals Inc., said the curious part about the bill is how it will save money. "I think Congress just got a little carried away at the end of this session with all this noise about drug prices and someone stuck this in the pipeline."
Berry disagreed, saying, "If you go to Canada and buy it for one-tenth of what you buy it for here - that's not rocket science - that's saving money."
He said competition here will keep the prices low and affordable.
When addressing the House Wednesday, Rep. John Dingell (D-Mich.) said competition does not guarantee a fair price. In fact, wholesalers may not pass on any accrued savings to the public, nor is it clear they will necessarily be able to access a steady supply for resale. "This bill is riddled with numerous loopholes that will allow manufacturers to label or produce their products in a form that makes them either impossible or cost-prohibitive to reimport. The notion that this bill will create an abundance of cheap, properly labeled and properly repackaged drugs, easily available to reimporters, is simply false."
The provisions will do nothing to help lower the price of prescription medicines and are no substitute for prescription pharmaceuticals to senior citizens under Medicare, Dingell said.
Jeff Trewhitt, spokesman for the Washington-based Pharmaceutical Research and Manufacturers of America (PhRMA), said if Congress was trying to resolve the prescription drug debate through this bill, "it probably would have been faster for them to try to get together on expanding drug coverage under an improved Medicare program. Congress could probably reach a bipartisan agreement on expanding drug coverage under an improved Medicare program long before reimportation to the United States."
Trewhitt says it likely will take two to three years before this program gets under way.
And once the measure becomes effective, the clock on the five-year sunset provision begins ticking. Since biologics are not included in the provision, biotechnology insiders are concerned about the sunset provision because it could make biologics vulnerable.
When asked whether he would consider adding biologics, Berry said, "My intent is to add biologics - in fact, I will do it quicker than that if I get a chance."