Pharmaceutical Industry

FDA Proposes to Expand Availability of Prescription Drugs

A spectacular overhaul in regulations by the Food and Drug Administration (FDA) would make experimental drugs more attainable to seriously ill patients who have no other treatment options, redefine when it is appropriate to turn to such medications and set new boundaries in regards to when drug manufacturers can charge for experimental drugs.

This proposed reform is carefully designed to balance several objectives, said Dr. Andrew C von Eschenbach, Acting FDA commissioner. One goal is to enable many more patients who lack satisfactory alternatives to have access to unapproved medicines, while balancing the need for safeguarding the individual patient. Another equally important goal is to ensure the continued integrity of the scientific process that brings safe and effective drugs to the market.

FDA hopes this proposal will increase awareness in the healthcare community of the range of options available for obtaining experimental drugs for seriously ill patients, said Dr. Janet Woodcock, FDA’s Deputy Commissioner of Operations.

Rule #1 is intended to modernize regulations to include any circumstances under which experimental drugs are permitted. It defines which individuals would be eligible and ensures that the potential benefit would justify any risks being taken. For the protection of the drug manufacturer, it promises that any therapy will not interfere with the drug's development.

Rule #2 makes experimental drugs more widely available in appropriate situations by establishing criteria that link the level of evidence needed to support the use of an experimental drug to the seriousness of the disease and the number of patients likely to be treated with the drug.

The third and final rule revises the current regulations regarding manufacturers’ recovery of costs of an experimental drug. It helps the drug companies by allowing them to charge patients in some cases while the drug is still under study. The motive for this is that by allowing manufacturers to recuperate funds, it will encourage them to provide early access to the drug.

The new regulations will undergo a ninety day review period before going into effect. physician marketing database.