WASHINGTON -- President Reagan signed legislation Friday 'with mixed feelings' permitting export of drugs not yet approved for use in the United States to foreign nations -- as long as they meet other countries' legal tests.
The measure, worked out by Congress after what was described as 'exhaustive negotiations' with the administration, was approved only hours before congressional adjournment last month.
The new law allows U.S. pharmaceutical companies to begin production of the drugs in this country for sale overseas while waiting for approval by the Food and Drug Administration to approve them for the American market.
Without the bill, U.S. companies would have to set up plants in foreign countries where they could produce the drug for any market.
The measure also allows the export of certain tropical diseases drugs not approved for use in the United States.
Sen. Edward Kennedy, D-Mass., called the bill 'vital legislation' and said that Reagan's decision to sign the measure 'is the best omen so far for a productive 100th Congress.'
Reagan said he had mixed feelings about his action.
'On the one hand, I warmly endorse provisions of this legislation permitting the export of unapproved durgs and biologicals uner certain conditions and repealing the federal health planning authorities,' Reagan said in a statement.
'On the other hand, I have serious reservations about the portion of the bill that would establish a federal vaccine injury compensation program,' Reagan said.
That provision, which ran into the stiffest initial resistance from the administration, is the no-fault provision applying to vaccines against various childhood diseases such as polio, measles, pertussis, diptheria, tetanus, rubella, mumps and smallpox.
The law provides compensation for the medical, rehabilitation and education costs for children who are injured by the vaccines, leaving the court process open only to those hurt or disabled through negligence.
Suporters of the no-fault provision claimed that most children never receive court awards because blame on the physician or manufacture cannot be proved and, in the case of those who are compensated, much of the money is eaten up by legal fees. They were also concerned that high insurance costs would lead pharmaceuticals companies to end production of the vaccines or to dramatically raise prices.
The legislation, however, provided no money for the estimated cost of $250 million needed for compensation under the no-fault program. It could not go into effect until Congress approves the financing, a point Reagan said was a 'major factor in my decision to approve' the bill.
'Despite these concerns, I believe the benefits of (the measure) outweigh its defects, and, therefore, with some reluctance, I am approving the bill,' Reagan said.
The new law also requires states to develop and put into force comprehensive program for the care of the chronically mentally ill, provides training in geriatric medicine, provides protection for physicians who police the work of their colleagues, and expands effort to eliminate Alzheimer's disease and to care for its victims.
Richard Godown, president of the Industrial Biotechnology Association, praised Reagan for making 'the right decision for the right resons: keeping U.S. jobs and technoogy at home, making safer biotech medicines availing to victims of disease in countries around the world, ensuring America's competative edge in biotechnology -- all while preserving the integrity of non-protectionist policies.'
