The new plan is designed to provide alternatives to patients with severe conditions that do not respond to currently approved therapies.

The proposition recommends experimental drugs be made available during all stages of development, including that of initial, phase-one testing.

As an incentive, research and development companies will be allowed to charge a fee for the drugs to help cover their high costs.

Experimental drugs have been available since the 1970's, however guidelines for their use have been unclear, resulting in many patients being unaware of, or unable to gain access to treatments.

"By clarifying and streamlining the processes, FDA hopes to encourage companies to make such drugs available, and reduce barriers for healthcare practitioners in obtaining them," explains Dr. Janet Woodcock, FDA's Deputy Commissioner for Operations.

The new regulations pertaining to access will clarify who is eligible to receive experimental drugs. The list will include single patients in emergency and non-emergency settings, small groups of patients, and larger groups of patients involved in a treatment IND (Investigational New Drug) program.

The new regulations pertaining to drug costs will explicitly state that charges only be allowed in the case of a drug that promises significant advantages over existing therapies. Additionally, money received from sales may apply only to the direct costs of the drug's development and distribution.

The FDA hopes this proposed system will increase awareness of the full range of experimental drugs available and ensure equal access to those treatments throughout the healthcare community.

The proposed rules are presented in detail and open for comment for 90 days at the FDA's website.