17
I thank you, Mr. Chairman, again for calling attention to this.
Anything any of the members of the committee can do to help me
pressure the Commerce Committee to move forward with some real
drug reform I think would be very helpful to the patients and the
citizens of this country in all due respect to humanity.
The CHAIRMAN. Thank you, Mr. Symms. We commend you, as I
said before, for your pioneering in this very critical area.
Mr. Ford?
Mr. FORD. No questions, Mr. Chairman.
The CHAIRMAN. Mr. Hopkins?
Mr. HOPKINS. Thank you, Mr. Chairman.
I want to join my colleagues on this committee in thanking
Congressman Symms for being here. For those of you who might
not know, he is one of the most outstanding members of this
Congress.
What we are really talking about I think is how safe is safe.
Certainly I think we all realize the fact that we have to have some
regulation in this country. Certainly the FDA does some good. The
fact is that the time involved for new drug approval has risen from
22 years to 10 years. In 1958, one new drug needed 430 pages of
submissions. But in 1968, a new anesthetic required documentation
totaling more than 72,000 pages and 176 volumes.
Certainly we need some regulation in this country, but I have
come personally to the conclusion that Government regulations are
excessive.
Congressman, I compliment you on the three bills that you have
introduced pertaining to DMSO. Are you optimistic, Steve, about
the enactment of these bills?
Mr. SYMMS. Not necessarily optimistic because I believe that the
FDA has the ability to prove DMSO without legislation by Con-
gress. As the gentlemen mentioned, how safe is safe? The FDA
properly stopped thalidomide from being used in the United States,
from being prescribed and put on the market, without the amend-
ments. That was pre-1962. But in the hysteria of the thalidomide
scare, and some of it was brought into this country from other
countries, the Congress in 1962 passed the amendments.
If you will note the dates of the figures that you gave in 1958 and
1968, the big increase has been in trying to prove that something is
efficacious. Safety is another matter. I think we all agree we
should try to prove safety. But the small entrepreneur drug compa-
ny is falling through the cracks because they cannot afford to do a
$20 million proving ground to prove that a product is efficacious.
The inexpensive, nonprofitable or less profitable drugs are not as
attractive now to the market. The result is that the big companies
get bigger and the small companies have a harder and harder time
competing in the marketplace.
So I am not so optimistic about our bill passing. I am pessimistic
about my Drug Reform Act passing because this is the third Con-
gress in which I have introduced this bill and we have not yet been
able to move it out of the subcommittee.
I would hope maybe in the future, with committees like this one
becoming more aware of the problem of what the amendments
have done, coupled with patent laws and other areas, that we can,
in Congress, move forward with a broad-based reform which would
