PHARMACY

Supreme Court will not hear case on experimental drugs for terminal patients

BY Drew Buono

WASHINGTON The Supreme Court has declined to consider whether dying patients have a right to be treated with experimental drugs not yet approved by the Food and Drug Administration, thereby making the ruling of the U.S. Court of Appeals for the D.C. Circuit which said the terminally ill have no rights in the matter stand as law, according to the Washington Post.

The challenge was brought by the Washington Legal Foundation and the Abigail Alliance for Better Access to Developmental Drugs. The alliance is headed by Frank Burroughs of Fredericksburg and named in honor of his daughter, Abigail Burroughs, who was diagnosed at 19 and died at 21 as a result of a rare form of cancer.

The groups’ petition told the court that “a terminally ill patient with no approved treatment options has a right to decide for himself, in consultation with his own doctor, whether to take a drug that the FDA concedes is safe and promising enough to be tested in substantial numbers of human subjects.”

Too many patients, they contend, cannot get into trials of the drugs “because they are too young, too sick, cannot qualify for the trial protocol, cannot travel, or because the trial is simply too small.”

U.S. Solicitor General Paul Clement said that FDA studies have shown that “preliminary expectations of safety and efficacy often prove to be unfounded, and drugs that initially appear promising are frequently found ineffective or even affirmatively dangerous to life and health.”

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FDA to open office in India

BY Drew Buono

KOCHI The Food and Drug Administration is planning on opening an office of its agency in India, in an effort to ensure the quality of the food and drugs being imported by the U.S., according to published reports.

Health and Human Service secretary Michael Leavitt and FDA commissioner Andrew von Eschenbach are in the country presently assessing the manufacturing practices existing at drug and food processing units.

According to Leavitt, he set up the mission because, “there was a serious apprehension among the consumers in this country on the quality of food and drugs being imported.” “We are trying to ensure the quality in the entire system of supply chain, right from the seed to the last outlet from where people buy the goods,” he said.

The U.S. imports about $56 million worth of food and drug products from India.

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BioDelivery works on risk management plan for dissolving fentanyl patch

BY Drew Buono

RALEIGH, N.C. BioDelivery Services International is planning on developing a safety plan for its new BEMA fentanyl patch, which the Food and Drug Administration accepted for review last week, according to published reports.

In December, a public health advisory from the FDA was released following reports of life-threatening side effects and even death associated with inappropriate prescriptions or use of the patches. So, to be safe, BioDelivery has developed a Risk Minimization Action Plan, or RiskMap, for its patch, which dissolves in the mouth and is placed on the walls of the cheek, unlike other fentanyl patches, which are placed on the skin and have to be disposed of.

Fentanyl is a narcotic pain medication more powerful than morphine. It has been in use for years. The FDA first issued a public health advisory for fentanyl skin patches in July 2005 following reports of the deaths of some patients.

BioDelivery’s vice president of marketing stated that the company is more confident as to the differences between its patch and other fentanyl patches, and believes the confidence is extended to how the drug is meant to be used and how the drug is delivered in the body.

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