Changes in the Food and Drug Export Trade Law that allow medical products not yet approved in the United States to be sold in countries where approval has been obtained will be a big benefit to American biotechnology businesses, according to Sen. Orrin Hatch, R-Utah.
He said the changes will give American biotechnology business "a level playing field" in the global marketplace and will eliminate the paternalistic American viewpoint "that we knew better than any other country what products they should import."Speaking Thursday in the Red Lion Hotel during a conference sponsored by the Utah Life Sciences Industries Association, Hatch said American manufacturers needed the change because the American deficit continues to rise.
"At the dawn of a new era in our understanding of biological science - an area of research where our nation leads the world - it is imperative that our country adopt policies that will allow patients to enjoy both the public health and economic benefits of taxpayer investment in basic biological science," Hatch said.
Tracing the history of food and drug laws in the United States, Hatch said Congress succeeded in 1986 in providing a measure of relief in the area of drugs when Hatch's bill was enacted that allowed export of unapproved human and animal pharmaceuticals to 21 countries.
Hatch said he wasn't entirely satisfied with the law because it was limited, but it "established the important precedent of allowing American medical products the Food and Drug Administration had not approved to be shipped overseas."
"That was the beginning of the end for the `FDA is the traffic cop to the world' mentality," the senator said.
He said changes in the law are having a positive impact on medical-device exports from the United States; in the first nine months of 1996, they totaled $8.3 billion compared with $7.3 billion in the same period a year ago.
The positive trade balance for medical devices is good news for American companies, and the companies producing pharmaceuticals also have good news because their exported products have increased 14 percent this year, Hatch said.
The senator said getting the bill passed was a bipartisan effort and came only after a struggle, but the benefits are already being seen.
For example, an American company shipped a left ventricular assist device to a Russian doctor operating on Russian President Boris Yeltsin. The device had been approved in The Netherlands but not the United States, and its shipment wouldn't have been allowed under the old law.
As it turned out, the device wasn't needed because the operation was a success.