Pharmacy Compounding Subject to FDA Approval?

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Pharmacy Compounding Subject to FDA Approval? The Facts Just Don't Fit

http://www.compoundingfacts.org/info.cfm?News_ID=84

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Over the past 15 years, there has been a fundamental disagreement between the

U.S. Food & Drug Administration (FDA) and the profession of pharmacy over the

legality of compounding.

The view espoused by the FDA is that compounding has been illegal ever since the

Federal Food, Drug, and Cosmetic (FDC) Act was passed in 1938. The compounding

profession disagrees, and the facts concur.

Recently, a landmark ruling in Midland, Texas, reinforced the view of the

pharmacy profession that compounded medicines are not new, unapproved drugs and,

subsequently, it is legal to prescribe and dispense them.

The Midland decision stops the FDA's encroachment on the authority of state

boards of pharmacy in its tracks and lifts the veil of uncertainty from pharmacy

compounding, allowing pharmacists to serve their patients confidently.

FDA's lengthy legal briefs against compounding can be boiled down to a very

simple argument: that every compounded drug is a new, unapproved drug and,

hence, subject to FDA oversight. FDA's argument primarily hinges on one

statutory provision in the FDC Act. This provision defines a new drug as " any "

drug that is not generally recognized as safe and effective by experts. FDA

argues that the word " any " is clear, simple, and unambiguous, and precludes

examining any historical facts.

The problem with FDA's argument is that the courts have repeatedly rejected it –

even before the Midland decision. Recently, the U.S. Supreme Court reviewed a

federal statute that imposed restrictions on individuals who had been convicted

by " any " court. The government argued there, as the FDA argues here, that " any "

means " every " and there are no exceptions. The Supreme Court rejected the

government's argument in that case, ruling that a Japanese court was not " any "

court for purposes of interpreting the law. In other words, the Court said that

courts should not read the word " any " literally as meaning each and every, and

should not ignore, as the government wanted, Congress' objectives and the

historical context.

This is not a new concept. The U.S. Supreme Court in this decision cited another

Supreme Court decision involving the word " any. " Thus, FDA's central argument

about how statutes must be interpreted – that the phrase " any drug " means every

single drug, without qualification – flies in the face of judicial precedent

going back two centuries.

FDA has cited no facts to support its position. Instead, FDA relies completely

on this statutory argument. However, the facts refute FDA's view.

* Fact: In 1938, when Congress passed the FDC Act, hundreds of millions of

medications were compounded annually. In fact, the health care system could not

have functioned without compounded drugs. As the executive director of the

Missouri Board of Pharmacy stated before Congress in 2003, " In fact, until after

World War II when drug manufacturing became more prominent, compounding was one

of the principal practices used to provide needed drugs to patients. " FDA's

interpretation of the law would have meant a complete breakdown in the delivery

of health care in the United States in 1938, when Congress passed the law.

* Fact: The legislative history of the FDC Act shows that Congress did not

intend to interfere with the practice of medicine. Depriving physicians and

patients of access to compounded drugs at a time when there were no alternatives

for most diseases would have caused an extraordinary disruption with medical

practice, and would have been contrary to Congress' intent.

* Fact: There is absolutely no indication from the legislative history that

anyone in Congress expected or intended for the FDC Act to turn compounding

pharmacists into criminals. FDA says that this silence shows that Congress did

not intend to confer an exemption upon pharmacists. In fact, the contrary was

true – no expressed exemption was needed because nobody ever contemplated that

compounding would be deemed illegal. Compounding had been practiced since the

early colonial days. Under FDA's theory, Congress fundamentally changed the

health care delivery system without anyone in Congress saying, or even hinting,

that they had just abolished compounding as a lawful activity.

* Fact: As of 1938, every state permitted compounding. Pharmacists were

licensed and trained to compound in every state. These state laws did not change

after passage of the FDC Act. Compounding remained a state-sanctioned,

state-licensed activity. Under FDA's theory, every state was authorizing

pharmacists to – and often even requiring pharmacists to – commit illegal acts.

* Fact: In 1938, pharmacy schools trained pharmacists to compound. Under

FDA's theory, these schools of pharmacy were teaching – and have continued to

teach – illegal conduct.

* Fact: The pharmacy groups were among the strongest supporters of the FDC

Act. The President of the American Pharmacists Association (APhA) was persistent

in supporting the bill, and praised Congress for passing the law. In fact,

pharmacy groups wanted the law passed because they were already heavily

regulated, and their competitors – drug manufacturers – were not. Under FDA's

theory, the pharmacy groups were supporting legislation that caused virtually

every pharmacist in the United States to become criminals.

* Fact: The United States Pharmacopeia (USP) contained monographs for

compounded drugs in 1938. In fact, Congress gave the USP special status under

the FDC Act. Under FDA's theory, the USP monographs for compounded drugs

established criteria for illegal products. In fact, since 1938, the USP has

added monographs for new compounded drugs, and more recently, standards for

compounding. Under FDA's theory, each new monograph has represented another

formula for another illegal product.

* Fact: The United States government has long engaged in the act of

compounding. Documents from the early 1940s give military pharmacists

instructions on compounding. The Department of Defense has continued to support

and utilize compounding. The U.S. Army offered formulas for pharmacists to

compound drugs from bulk. Under FDA's theory, every military pharmacist who

compounds is breaking federal law. This would create a terrible dilemma for

military pharmacists – filling an order to compound a drug would mean to follow

an illegal order.

* Fact: The federal government provides reimbursement coverage for

compounded medications. Under FDA's theory, the U.S. Government is paying for an

illegal product.

* Fact: The FDA itself did not take the view in 1938 that compounding was

illegal. There is no evidence whatsoever that FDA, in the wake of the passage of

the law, told pharmacists that their behavior was illegal. In fact, in

subsequent publications for pharmacists talking about the FDC Act, FDA described

multiple provisions of the law, but did not tell pharmacists that one effect of

the law was that compounding had become unlawful.

* Fact: There is no contemporaneous evidence that anyone thought that

compounded drugs would become illegal new drugs as a result of the 1938 FDC Act.

No one in Congress, no one from FDA, no pharmacist, and no witnesses before

Congress ever said or suggested such a thing. Under FDA's theory, the U.S.

health care system was being transformed, and nobody ever said a word about it.

FDA has argued that Congress passed the law to give FDA the discretion to

regulate compounding. In fact, there is no evidence at all that Congress or

anyone else thought it was conferring upon FDA any authority over compounding.

Nor is there any evidence that Congress intended for compounding to survive

solely at the discretion of FDA.

* Fact: In 1970, Congress passed a law regulating controlled substances. It

gave an exemption for compounding pharmacists under certain circumstances. The

U.S. Drug Enforcement Administration's (DEA) implementing regulations also gave

compounding pharmacists an exemption. Under FDA's theory, Congress outlawed

compounding in 1938 and then in 1970 exempted this illegal behavior from certain

provisions of the DEA laws. There is no evidence that in 1970 Congress

considered compounding to be anything other than a lawful, medically necessary

practice.

* Fact: Compounding remains ubiquitous, in the retail setting, in hospitals,

and elsewhere. There is no disputing – even by FDA itself – that compounding

remains medically essential. Under FDA's theory, compounding pharmacists who

perform this essential, life-supporting service have been criminals since 1938,

protected from prosecution only by FDA's willingness to exercise its enforcement

discretion.

* Fact: Until relatively recently, FDA did not take the position that all

compounded drugs were unapproved new drugs, and therefore illegal. If, as FDA

now argues, the plain language of the statute makes it crystal clear that every

compounded drug is illegal, one would have expected FDA to have articulated this

theory well before a half century elapsed.

In fact, evidence discovered during the Midland case proves that FDA

acknowledged internally in 1989 that this novel theory was a break with

tradition. In a memo dated August 2, 1989, the FDA's Office of the General

Counsel wrote in a memo that its new legal theory on compounding, among other

things:

* " is a departure from the traditional approach we have taken; "

* " would likely face a variety of practical problems, including

jurisdictional issues; "

* " would require the establishment of new legal precedents; " and

* " leaves pharmacists in the objectional [sic] position of `living in sin.' "

FDA has no facts to supports its position, as evidenced by its recent loss in

Midland, Texas. When Congress passed the FDC Act in 1938, nobody – Congress,

pharmacists, states legislatures, state Boards of Pharmacy, USP, the U.S.

military, or FDA – thought that Congress had banned compounding. Nobody said a

word about this dramatic shift in health policy. It was not until 50 years later

that FDA reinterpreted the law to say that a linchpin of the health care system

was a criminal act.

The courts have developed principles for interpreting this type of silence. In a

less legalistic way, so did Sir Arthur Conan Doyle. In his famous story Silver

Blaze, the following exchange took place:

Colonel Ross: " Is there any other point to which you would wish to draw my

attention? "

Holmes: " 'To the curious incident of the dog in the night-time. "

Colonel Ross: " The dog did nothing in the night-time. "

Holmes: " That was the curious incident. "

The utter silence regarding any intent to ban compounding, combined with massive

accumulation of facts rebutting FDA's newly minted theory, shows that FDA's

interpretation is simply wrong and would keep millions of patients from

receiving essential treatment. For these patients with unique needs that are

unmet by off-the-shelf pharmaceuticals, compounded medications—prescribed or

ordered by licensed physicians and mixed by trained, licensed compounding

pharmacists—are the safest and most effective way to better health.