Monday, August 17, 2009

FDA issues final rules to help patients access investigational drugs

As HemOnctoday reported August 13th/09:
The FDA has published two new final rules explaining how critically ill patients can get access to investigational therapies when they are ineligible for clinical trials and do not have other treatment options.

The first rule, “Expanded access to investigational drugs for treatment use,”
clarifies procedures and standards with the aim of making investigational drugs
more widely available. It clarifies existing regulations and adds new types of
expanded access for treatment use. Under the final rule, expanded access to
investigational drugs for treatment use will be available to:

- Individual patients, including in emergencies.

- Intermediate-size patient populations.

- Larger populations under a treatment protocol or treatment investigational
new drug application (IND).

The second rule, “Charging for investigational drugs under an investigational
new drug application,” spells out the specific circumstances and costs for which
a manufacturer can charge patients for an investigational drug. The rule revises
the charging regulation to:

- Clarify the circumstances under which charging for an investigational drug
in a clinical trial is appropriate.

- Set forth criteria for charging for an investigational drug for the
different types of expanded access for treatment use described in FDA’s final
rule on expanded access for treatment use of investigational drugs.

- Clarify what costs can be recovered.

The agency has also launched a website for patients and physicians seeking more information about their options with regard to these investigational drugs. It includes information on treatment with an FDA-approved drug, treatment with an investigational drug as part of a clinical trial or obtaining access to an investigational drug outside of a clinical trial.
“With these initiatives, patients will have the information they need to help them decide whether to seek investigational products,” Margaret A. Hamburg, MD, commissioner of food and drugs, said in a press release. “For patients seeking expanded access to investigational drugs and biologics, the new rules make the process easier to understand.”

This is the direct link to the FDA post:


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Pharmacy History

"The earliest known compilation of medicinal substances was ARIANA the Sushruta Samhita, an Indian Ayurvedic treatise attributed to Sushruta in the 6th century BC. However, the earliest text as preserved dates to the 3rd or 4th century AD.
Many Sumerian (late 6th millennium BC - early 2nd millennium BC) cuneiform clay tablets record prescriptions for medicine.[3]

Ancient Egyptian pharmacological knowledge was recorded in various papyri such as the Ebers Papyrus of 1550 BC, and the Edwin Smith Papyrus of the 16th century BC.

The earliest known Chinese manual on materia medica is the Shennong Bencao Jing (The Divine Farmer's Herb-Root Classic), dating back to the 1st century AD. It was compiled during the Han dynasty and was attributed to the mythical Shennong. Earlier literature included lists of prescriptions for specific ailments, exemplified by a manuscript "Recipes for 52 Ailments", found in the Mawangdui tomb, sealed in 168 BC. Further details on Chinese pharmacy can be found in the Pharmacy in China article."

From Wikipedia:

Journal of Palliative Medicine - Table of Contents

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