(B5)

New York
heart patients
proved that all
these generic drugs
were not equal.
They died.

Soon, Oklahoma law may give you the chance to test the equality of generic medicines for yourself.

The heart medicine was all seemingly the same it had the
same chemical compound as the effective prettype drug
But in spite of that parents reacted violently to the sight
differences Thay suffered hean attacks They died

And now everyone's witing to admit that yes this
particular medisine does differ radically from manufacturer
to manufacturer even though its chemically the same
But for those patients in New York, the admission came
too late

trs not to late for us here in Oklahoma
preposterous law has been proposed that would mean
your doctor may not be remen that the drug he knows
and trusis and which he has prescribed for you w
fact be the drug you get when your prescription is tied.
But it's not law yet. And it shouldn't be

We've already seen one tragic instance where all genere
Brugs were not equal Ase your doctor There are others
Like the man in California who found that all gerencatly
equal antar rabers weren't the same after 15 of
them dan disave in his stomach and he had to have
them surg caly removed along with 7 inches of
his intestine"

The fact is, the government doesn't even require that all
generic drugs be equal. They need only meet minəmymə
blandards to be on the market

Now could anyone even propose presenetian drug

No supporter of prescription drug substitution has yet
proved that this law will save you more than about 20 on
the dolar And we must as in all sincerity, what good is
saving money on medicine of the medicine doesn't save
Your bife?

As we said, there's no law that says we have to have
prescription drug substan yet. But unless you act
DOM and urge others to act, tes were really
genna get Really

Call this number for more information If you re already
convinced teri us when you can we it send a protest in
your name to the people in Oniatoma Citywne can
prevent ins 0-333! Your state leg stators or wide
them yoursel But dont was Now is the time to take
echian Write your own leg or

Call 332-4116 Now!

-35

When you're
critically ill do you
want a politician or
your doctor to
decide what medicine
you get?

and the Evening News, Ada, Oklahoma.

Fublished in the News-Star, Shawnee, Oklahoma,

You trust a politician enough to vote for him

Does that mean you trust him enough to
dictate the medicine you and your famaly
should take?

When he decided that's what it means, it's time
to get worried.

Like now.

Some of them have decided they know enough
to severely limit your doctors ophions as to
what medicine he gives YOU.

No kidding

The proposed law involves prescription drug
substitution The selling points that generic
for chemical) name drugs are usually cheaper
than brand name medication

And since all drugs with the same chemical
name 29 not the same therapeutically, why
shouldn't your doctor be the one to prescribe
the medicine he wan's you to get and have the
assurance that you'll get it? Generic drugs are
not required to meet equal quality control
standards for purity or processing, but only
minimum government levels

We're here to tell you. And if you value your
health and your money, we suggest you read

"Chemically equal does not, REPEAT NOT.
mean therapeut.cany equal Therapeutic
action refers to the way the drug acts in your
body Differences in quality compres füler
acidity and absorption rates will cause the so
called chemically equal drugs to act difierently
in your body

And the inequalities that exist

Can But you Like the heart patients in
New York who died because different
batches of the same hean medicine
coured heart attacks

Can maim FOU Like the man in
Caldornis who had 7 inches of Ar
Intestines and 150 antacid tablels
removed Burgically because inay
wouldnt Cssolve in his stomach

This campaign to Stop

Prescription Drug Substitution

Legislation is sponsored by

Can make you a whole lot sicker: Like the
untold millions who have suffered penicillin
reactions because of impurities in the drug.

Second, the drugs won't be cheaper Despite
grandiose claims nobody s proved that
prescription drug substitution can save you
more than 2 on the dollar on your medicine
But if the cheaper drugs don't work and you
have to pay for repeated visits to the doctor.
plus additional medicine have you really saved
any money at all?

You sent some of these people to Oklahoma
City to represent you. Now it's time to give
them a hand.

Call this number for more information on the
-prescription drug substitution leg station now
pending if you're already convinced. tell us
when you cal We send a piciest in your
name to your State Senator and State
Representative or you can write them yourself.
Bul cum mact Now is the time to take action.
Write your letters or

Call
332-4116
Κουν!

The alternative is enough
to make you sick.

Medicine
Hand Politics
don't mix.

the Pontotoc Medical Society and the Ada Pharmacists Association.

You trust a politician enough to vote for him. Does that Oklahoma, it's time to get worried. In eleven of our
mcan you trust him enough to dictate the
conditions your pharmacist must follow in filling
prescriptions? When he decides that's what his
legislative position means, it's time to get worried. Like
now. In eleven states they've already passed drug
substitution laws that mean patients can't be sure
they'll get the exact medicine their doctors prescribe.
Thay may wind up with a similar but cheaper drug.
That'd be fine if all the medicine was equal. But it's not.
And the differences can make you a whole lot sicker
than you already are... it has happened elsewhere,
and it can happen here. If you don't act now,
it's going to happen. Right here in Oklahoma. You sent
poople to Oklahoma City to represent you in state
government. On this issue you had better let your
legislators know how you feel. Call (Shawnee:
273-8838) (Ada: 332-4116) and voice a protest
against prescription drug substitution. Do your
part... medicine and politics don't mix.

sister states, the politicians have decided they're
as qualified as your doctor is to prescribe your
medicine. So they've passed laws-drug substitution
laws that fly in the face of everything a doctor
has spent years learning. If their law passes,
all the doctor would be able to do would be to indicate
a general type of medicine... not the specific
brand that he knows and trusts. That'd be fine if all the
medicine was equal. But it's not. And the differences
can kill you, can maim you, can make you a whole lot
sicker than you already are. In documented instances it
already has. Oklahoma, it's time to get worried 'cause
the first step in such a program has passed
the House and is pending in the Senate. Stop
pending drug substitution laws now. Call (Shawnee:
273-8838) (Ada: 332-4116), get the facts and voice a
protest, because medicine and politics don't mix.

Broadcast over radio stations KGFF, Shawnee, Oklahoma, and KTEN, KEOR, and KADA, Ada, Oklahoma

MARCH 1976. PRIVATE PRACTICE 15

Statement of

C. Joseph Stetler
President

Pharmaceutical Manufacturers Association

Before the

Subcommittee on Monopoly

Senate Select Committee on Small Business

November 16, 1977

Mr. Chairman and Members of the Committee:

I am C. Joseph Stetler, President of the Pharmaceutical Manufacturers Association. With me today are Bruce J. Brennan, PMA Vice President and General Counsel; and Dr. John G. Adams, PMA Vice President, Scientific and Professional Relations.

We appreciate the opportunity to testify this morning on two issues which pertain to your current hearings on drug quality, competition and government procurement of drugs. The first is the so-called list of interchangeable drugs recently published by the New York Department of Health under the title "Safe, Effective and Therapeutically Equivalent Prescription Drugs". The second is the Maximum Allowable Cost regulation of the Department of Health, Education, and Welfare.

The New York drug list, which was released in draft form on October 1, is intended to implement recently enacted drug substitution legislation in New York. The new law requires that all prescription forms in the state carry two instructions to the pharmacist to be executed by the prescribing physician. The first authorizes the pharmacist to substitute a product of the same chemical composition for the one prescribed. The second requires that the pharmacist fill the prescription with the specific product indicated. The law requires that whenever authorized, a substitution must be made if the substitute product appears on a special list developed by the New York Department of Health.

This list of allegedly equivalent drug products was not prepared by the Food and Drug Administration or by experts in medicine or pharmacology. It was developed under no scientific or research protocol. It originated in the New York Office of Legislative Oversight and Analysis and is nothing more than a compilation of data from FDA files.

This list of products of firms holding approved New Drug Applications or Abbreviated New Drug Applications is now being promoted as a definitive, scientifically accurate statement on therapeutic equivalence as if it were a revelation. In fact, the public really has no more assurance about product equivalence now than it did without such a list. The identity of holders of NDAs and ANDAs for the products shown has been a matter of public record for

years.

We think it is extremely important that the public and legislators understand that significantly different criteria are applied among companies and among products in the course of approving NDAs or ANDAS. FDA approval is not, and was never intended to be a permanent guarantee of safety and efficacy. Nor is such approval a guarantee that the product is interchangeable with any other chemically similar drug or that it is therapeutically equivalent to it.

New York officials, as well as certain Food and Drug Administration employees, have attempted to deal with the difficult issue of interchangeability by offering a list of products, as a group, which present no known problems. Indeed, the statements by FDA and New York officials have to be read very carefully. They say that FDA has not yet heard about any medical difficulties arising from the indiscriminate substitution of one of these products for another. The fact is, FDA is really not looking for any such problems, and doesn't know whether any exist or not.