|
Editorial: Court Decision Supports Compounding
(Editor's Note: We will interrupt our series on the USP General Notices this week to report on a major court decision this week that supports pharmacy compounding.)
On Monday, Judge Timothy J. Corrigan of the U.S. District Court for the Middle District of Florida ruled in favor of Franck's Pharmacy and held that the FDA lacks the authority "to enjoin the long-standing, widespread, state-regulated practice of pharmacists filling a veterinarian's prescription for a non food-producing animal by compounding from bulk substances." United States v. Franck's Lab, Inc., No. 5:10-cv-00147, slip op. at 79-80 (M.D. Fla. Sept. 12, 2011).
In April 2010, the U.S. Food and Drug Administration (FDA) filed a highly publicized complaint seeking to enjoin Franck's veterinary compounding practice based on the novel legal theory that animal medications compounded from bulk ingredients constitute "new animal drugs" that cannot be distributed without an FDA-approved new animal drug application. The case was of national importance in that the FDA stated that Franck's Lab, Inc.—and all other pharmacists involved in compounding veterinary preparations with active pharmaceutical ingredients (API)—were in direct violation of the Animal Medicinal Drug Use Clarification Act (AMDUCA), the FDA's Compliance Policy Guide (CPG), and the Food Drug and Cosmetic Act (FDCA) because those preparations are "new drugs" and subject to FDA review and approval. Franck's argued that the traditional, state-licensed pharmacy practice of compounding commercially unavailable veterinary medications when prescribed by a Veterinary Doctor from bulk ingredients is lawful.
At no time, as the government's complaint makes clear, did the government make any allegations, or even intimations of allegations, as to the quality of Franck's compounding practices.
In the 80-page decision, Judge Corrigan explained that "[t]he undisputed evidence [that the practice of compounding animal medication from bulk ingredients is an essential component of veterinary medicine] shows that allowing the FDA to enjoin a pharmacist's traditional, state-authorized practice of bulk compounding of animal drugs could destabilize the pharmacy profession and leave many animal patients without necessary medication."
"Veterinary compounding is a longstanding, recognized and medically vital service," said Paul Franck, owner of Franck's Compounding Lab. "We have been compounding human and veterinary drugs for more than 28 years and we are as committed as ever to meeting the special needs of doctors, veterinarians and their patients."
The decision states:
- The FDA does not have jurisdictional authority over the compounding of medications by a licensed pharmacy so long as the pharmacy's activities are not manufacturing. That rests with individual state Boards of Pharmacy.
- Congress did not give FDA jurisdictional authority when it enacted the FDCA in 1938 to take enforcement action against a pharmacy that is engaged in the traditional practice of compounding.
- The FDA cannot use its CPG for veterinary compounding issued in 2003 as the basis for enforcement action.
- The regulations enacted by the FDA based upon AMDUCA are in error—AMDUCA did not give the FDA authority to prohibit the use of bulk APIs in veterinary compounding.
- Size and scope of compounding does not mean a pharmacy is a manufacturer.
- The use of bulk APIs in compounding for humans and the prohibition of bulk APIs for compounding for non-food producing animals is an illogical position for the FDA to take and contraindicated by its own actions over the past 50+ years.
Loyd V. Allen, Jr., Ph.D., R.Ph.
Editor-in-Chief
|
|
FDA to have Authority for the Modern World
It seems to some in Washington that the FDA needs more authority to safeguard the pharmaceutical industry's global supply chain. Deborah Autor, a deputy commissioner at the FDA, states that the agency has limited ability to conduct regular inspections of foreign suppliers or to block products and ingredients imported by suspect companies. "The law is not clear on our ability to do that,'' Autor said. "The law puts the burden on the FDA to keep products out of the country, but the agency has to prove there's something wrong."
Foreign suppliers are responsible for importing 80 percent of the active ingredients used in the U.S., according to the Pew Health Group's estimates. The issue of the FDA's limited authority isn't new. The generic companies want legislation that would essentially modernize a1938 law, making the FDA more capable of ensuring the safety of a more global, complex supply chain. Members of the Generic Pharmaceutical Association and officials with the Pew Health Group have said the FDA's inability to inspect foreign plants and keep accurate, updated databases on foreign suppliers continues to pose risks to the pharmaceutical supply chain.
http://www.nj.com/business/index.ssf/2011/09/congress_mulling_changes_to_78.html
Alzheimer's Patients May Be Helped by Nasal Insulin
(1) Nasally administered insulin seems to improve cognitive function in Alzheimer's patients, according to research appearing in the Journal of Neurology. Nasal delivery results in the drug reaching the brain and central nervous system (CNS) fast. Researchers say insulin plays a role in the CNS and those who suffer from Alzheimer's experience a loss of insulin levels and activity. It's well known that insulin plays an important role in blood-sugar regulation in the body, and this work suggests that it has a number of different and important roles in the brain as well.
http://www.fiercedrugdelivery.com/story/nasal-delivery-insulin-appears-help-alzheimers-patients/2011-09-14?utm_medium=nl&utm_source=internal
(2) The results are preliminary and must be viewed with caution, "it is a provocative study," said Dr. Jason Karlawish, an Alzheimer's researcher and ethicist at the University of Pennsylvania. He and other experts caution that a bigger and longer study is needed to see if the initial results hold up and whether there are adverse effects that might negate any benefits.
Brain cells need insulin and conditions in which the body makes too little insulin or is resistant to its effects—diabetes, prediabetes, even untreated high-blood pressure—are associated with an increased risk of Alzheimer's. The insulin solution was administered using a special device made by Kurve Technology that delivers a spray of insulin deep into the nose. Alzheimer's patients should not rush out and try to take insulin. It is too soon to say if the treatment is even safe, and patients would need the special Kurve device to get it deep into the nose, which is not yet on the market.
http://www.nytimes.com/2011/09/13/health/research/13alzheimers.html?_r=1
Vitamin B May Help Stave off Alzheimer's Disease
Vitamins B complex and folic acid may dramatically slow the onset of memory loss in old age and even protect against Alzheimer's disease, researchers have found. They found that it reduced memory decline by 70 per cent in some elderly people. The combination also halved the rate of brain shrinkage in some patients—a physical symptom associated with forgetfulness that can lead to full-blown Alzheimer's disease. A full scale trial is expected to begin within the next year.
http://www.telegraph.co.uk/health/healthnews/8760703/Daily-Vitamin-B-pill-can-help-stave-off-Alzheimers-disease.html
Allergan Testing Eyelash Lengthener for Baldness
Latisse (Allergan) has moved into the second clinical stage of testing as a therapy for baldness and expects to see data by the middle of next year. Latisse was approved in 2008 to aid in eyelash growth, and generated $82 million last year for the Irvine, California-based company. Allergan is currently testing Latisse for men and women. It will grow hair from the existing follicle, and helps to maintain current hair.
http://www.bloomberg.com/news/2011-09-12/botox-maker-allergan-tests-eyelash-lengthener-for-baldness.html
|
