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FDA Shortens Experimental Drug Access Process

When you or a loved one is facing what appears to be a terminal illness treatment decisions can be difficult. Not only do you often have to learn a lot to truly give informed consent to the available treatments, but in the case of experimental treatments even more issues arise. The experimental nature of these treatments means that there is no guarantee that they will work and no guarantee that they will not make your situation even worse than it already is, but on the other hand such a treatment may present the only chance there is of recovery.

Some patients are pushed into these treatments and medications without truly understanding the consequences while others who know what they are getting into are denied access to potentially life saving or lengthening treatment. The red tape patients and their doctors have to go through to get access to these treatments can be prohibitive. This conflict is real and difficult to resolve. In light of it, the Food and Drug Administration (FDA) has now announced that it will make access to these treatments easier for patients.

FDA Announces New Policy

Dr. Peter Lurie, the associate FDA commissioner for public health strategy and analysis, announced earlier this month that the FDA has a new policy that is aimed at expanding access to investigational drugs. The policy is not yet officially in place yet but the form that will be used in the new process to get access to these drugs more quickly has been released to the public for comment. Rather than having to swim through a sea of red tape in order to get approval to use a treatment, the paperwork will consist of a reasonable two-page form. This is much simpler that the previous paperwork which called for 26 separate types of information and seven attachments.

Now, this is not at all to say that insurance companies will suddenly jump on board for paying for these treatments, but it does mean that the doctors and hospitals will have much less to do in order to get access to the treatments for patients. It also theoretically could drive down administrative costs of administering these treatments since there would be less paperwork to do, although that remains to be seen.

This New Policy Could Save Lives

While informed consent is especially important when it comes to experimental treatments, when that consent is obtained this streamlined process could save lives. Of course that depends on the efficacy of any given experimental treatment, but every treatment that has ever worked has been experimental at some point. Cronkite News reported on this new policy and interviewed families who have been previously denied access to medical treatment.

One mother spoke of her eleven year old son who woke up one day with knee pain. It turned out he had a rare bone injury and neither surgery or chemotherapy worked. A doctor told his mom about an experimental treatment that could prevent the cancer from spreading that was approved in other countries but not here. The family had to move to Paris to get the boy his treatment, and now he is doing fantastically. A man told the story of his daughter who could not get access to an experimental drug to treat her head and neck cancer. She died four and a half years before the drug was approved in the United States. Had she had access, her result may have been no different, but the treatment also could have saved her life.

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