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FDA looking for even more control over our health choices

Imagine that you had a child with a history of life-threatening allergic reactions. Your child develops a raging infection, which requires treatment with a specific class of antibiotic. The problem is, that antibiotic contains yellow dye #5 – a substance that you know would induce a severe reaction in your child. What would you do?

Or, say you suffer from an extremely rare condition that is controlled by a specific prescription drug. But the patent expires, and the pharmaceutical company decides that there isn’t enough demand for the drug to justify the expense of a patent renewal and continued production. You need the medicine to manage your symptoms – but now the drug will no longer be available. What options do you have?

Both situations present formidable obstacles. But the good news is, both share the same solution – compounding pharmacy. Compounding pharmacists can reformulate drugs with expired patents, deliver medications in alternate forms, remove allergy-inducing dyes and fillers, and resolve hundreds of other obstacles that can get in the way of following the prescriptions you need. For many, compounding pharmacy provides a life-saving service.

Yet, if the meddlers in Washington have their way, you soon won’t be able to FIND a compounding pharmacist – they’ll have been regulated right out of business.

Apparently, the FDA doesn’t think free speech applies to alternative medicine

In late October, the U.S. Supreme Court agreed to hear a case that will decide if the government can regulate compounding at local pharmacies. Although the case (known as Thompson v. Western States Medical Center, 01-344) won’t reach the Supreme Court until 2002, its roots reach back to 1997. That’s when Congress passed the Food and Drug Administration Modernization Act (FDAMA), which, among other things, restricted compounders’ abilities to advertise their services and wares. Pharmacies in Nevada filed suit against the federal government, charging that the restrictions violated the free speech clause of the First Amendment. A federal appeals court agreed with them, and went one step further, saying the entire compounding section of the FDAMA was unconstitutional. Now the FDA has appealed that decision to the Supreme Court.

According to a report by the Associated Press, the Bush administration urged the court to take the case, “arguing that there were serious health implications in allowing unregulated drug-mixing.” In one communication, the AP says Bush administration officials told the Supreme Court that unrestricted compounding “would seriously impair the integrity of the drug approval process.”

Excuse me, but could someone please show me the so-called “integrity” in the drug approval process? I guess I haven’t been paying close enough attention. And what exactly are these “serious health implications”? Tell that to the thousands of people who depend on compounding to AVOID the serious health implications of mass-produced commercial drugs.

What all this really comes down to is money. The FDA and pharmaceutical companies are afraid of compounding because they can’t control it – which means they can’t profit from it.

You see, compounding pharmacists don’t just count out and measure mass-produced drugs as most pharmacists do. Compounders work with your doctor to create a medicine that best fits your specific needs. Ingredients, dosage, concentration, delivery method, flavoring – all of these variables are within the control of the prescribing physician and compounder. For example, a compounding pharmacist can combine two medications into one pill, or formulate some medications into lotions, eye drops, lip balms, nebulizer solutions, or suppositories. They give you options where you thought there were none.

It’s not just a matter of convenience – in many cases, compounding comes to the rescue in life-threatening situations. For instance, many critically ill patients in hospice care rely on compounded medications because they are unable to swallow pills. I’d like to see the FDA talk to them about “serious health implications.”

Pharmacists are professionals – let’s treat them that way

We’re not talking about any old Joe playing mad scientist with a bunch of controlled substances. We’re talking about licensed, educated pharmacists with years of training. They cannot dispense any medications, compounded or otherwise, without a doctor’s prescription. In fact, doctors are the ones who usually initiate the compounding order, asking the pharmacists to formulate the medication according to his or her specifications. All of the ingredients are approved drugs listed in the U.S. Pharmacopoeia National Formulary (USP/NF), an encyclopedia of all drugs approved by the U.S. Pharmaceutical Convention. There’s plenty of regulation here already (and I mean plenty). So let’s let pharmacists be pharmacists, not just glorified pill-counters.

From listening to the FDA, you’d think that there were compounders on every corner. But the truth is, the use of compounding is not that wide spread. Many people are still not aware of compounding, and those who are aware often have difficulty finding a compounding pharmacist in their area, or a doctor who is comfortable working with one. With such a low profile, it hardly poses a threat to the billion-dollar-a-year pharmaceutical industry. The few dollars they may lose to compounding is certainly no reason to eliminate a powerful alternative that offers so much help to so many.

At HSI, we’ve done our best to spread the word. Our members will remember our in-depth coverage of compounding pharmacy in the May 2000 issue of the Members Alert newsletter. If you’d like to find a compounding pharmacist in your area, go to the International Academy of Compounding Pharmacists’ website at iacprx.org, where you’ll also find additional information for you AND your doctor on the benefits of compounding.

There’s nothing we can do to influence the Supreme Court decision. But we can keep up our fight against the forces in Washington that continually seek to limit our choices about our own health. Write to the FDA and tell them that you don’t appreciate their vendetta against compounding pharmacy. You can send your message to the FDA from their website, at http://www.fda.gov. You can also write to your senators and representatives in Congress and tell them that you support compounding pharmacy. For an email directory of all the members of the House of Representatives, go to house.gov/writerep; for an email directory of the Senate, go to senate.gov. Finally, forward this message to anyone you think would be concerned about the government taking away their right to work with their own doctor and pharmacist to protect themselves.

We need to let the “powers that be” know that we ARE paying attention – and that we want them to let us make our own choices when it comes to our health care.

Sources:
(1) “Court to Consider Drug Mixing Case,” Associated Press, October 29, 2001

Copyright 1997-2002 by Institute of Health Sciences, L.L.C.

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