Background
Personal Letter from the Elected Plaintiff for the Midland Legal Fund
Let me introduce myself. My name is A. Sam Kelley. I am the President of Applied Pharmacy Services in Mobile, Alabama as well as one of ten plaintiffs suing the FDA for all compounders’ rights. Last year a drug company filed a complaint with the FDA alleging my pharmacy had copied their patented drug. Without a shred of evidence, the FDA came in on an unannounced inspection. Even though they could not find a single dose in the strength or delivery system of the manufacturer’s brand, the FDA's inspection continued through my pharmacy for two days. It was in that moment that I decided I would join Dr. Steven Hotze’s suit and fight not just for my rights, but for the rights of every compounder, doctor, pharmacists, and patient to be free from the interference of the Federal Government.
The history of the FDA and Compounders is that of a long and difficult battle. In 1997 the FDA Modernization Act prohibited licensed drug providers from promoting or advertising particular compound drugs. This act brought about Thompson v. Western States Medical Center 535 U.S. 357 (2002) which resulted in the Supreme Court ruling in favor of all compounders. They stated that the FDA’s new guidelines were an unconstitutional restriction on commercial speech. In 2003 the FDA began enforcing the compliance policy guideline (CPG) which brought about Medical Center Pharmacy et al. v. Ashcroft et al. 7:04-CV-130 This suit was filed not only for my benefit but for the benefit of all independent Pharmacies offering compounding services for people, animals and the industries that support them.
The latest stab by the FDA was in U.S. District Court, Midland-Odessa Division where they filed a motion to dismiss hearing. The FDA attorney, Gerald Kell, stated, “we consider all compounding to be essentially illegal.” It became clear to me that a total elimination of compounding was their intention. Until then we had operated under the assumption that as long as we followed the “CPG,” we would be safe. That is no longer the case. The FDA, with the encouragement of pharmaceutical manufacturers, desires the elimination of compounding altogether.
Well guess what… that is not what Congress intended! In 21 U.S.C. §§ 360(g)(1), 374(a)(2)(A), (see Exhibit A) it clearly affirms that State Compliant Pharmacies are exempt from FDA oversight. This statue is made known, on page 2 of our law suit, which states that unless they are in violation of The State Board of Pharmacy rules, the FDA cannot illegally invade compounding pharmacies.
This is a fundamental part of our complaint. Let me ask you this - can any other law enforcement agency come in and search your business without a warrant? Should any agency be allowed to initiate an inspection based solely on a call from an adversary? Well of course they shouldn’t! So why does the FDA insist on unauthorized inspections, unlawful interventions, and intimidations? The answer is obvious… they are under enormous pressure from manufacturers to stop compounding altogether. This suit is intended to put an end to the harassment and remind the country and Congress that the FDA’s responsibility is to “protect the public heath” not to side with one industry over another.
Just recently, I was elected by my fellow plaintiffs to seek out other Compounders across the country who also share our views and want to help with our fight. We created The Midland Legal Fund, which is designed solely to pay for the growing cost of this law suit. On behalf of everyone with an interest in compounding, we have raised and spent almost $1 million dollars to date. Gathering the best attorneys, the most knowledgeable witnesses and top industry experts takes money.
So far, most of the funding has come from the 10 Pharmacies that launched this suit, and from associated organizations like IACP and, PCCA. Now we need your help to continue fighting for all compounders’ rights. As one of you, I understand how scarce your time and money is. I would not be asking for these precious resources if I did not believe that every compounder will be affected by the outcome of this suit.
I also have included updates and other related materials to demonstrate the depth and determination of our efforts to protect the compounding industry. Please look through the information and see how hard we have been fighting for your rights. Then decide how much you are willing to contribute to keep the right to compound. You can use the donation form attached or reach me at the contact information listed below. Let’s stand up against unfair and illegal treatment by the FDA and make sure they don’t put an end to our industry.
So far this year we have raised over $990,000! Our year-to-date total payment to Hance Scarborough Law Firm is over $430,000, and to Duane Morris Law Firm is more than $540,000. We also had to call in expert witnesses which cost more than $10,000. All of these fees have been paid out of our own pockets, and now more than ever we need the help of our fellow Compounders. Thanks again for helping us defend and support compounding.