Senator Cruz Encourages FDA to Expand Number of Conditions Covered by Parallel Track Policy

In a letter to Dr. Norman Sharpless, the acting commissioner of the Food and Drug Administration since April 5, Senator Ted Cruz encouraged the federal agency to expand the number of conditions covered by its Parallel Track program. The program, first launched in 1992, was the first of its kind – allowing people with HIV/AIDS to access experimental drug therapies years before they would be approved by the FDA.


Our scientific understanding of the human immunodeficiency virus (HIV) and the related acquired immune deficiency syndrome (AIDS) have improved dramatically since the earliest years of the AIDS crisis in the 1980s. That said, as with any any public health concern, HIV/AIDS education is important to ensure that the general population has an informed understanding of the risks, treatments, and prevention techniques thereof.

HIV is a virus transmitted between humans through certain bodily fluids (including breast milk, blood, semen, pre-seminal, rectal, and vaginal fluids). Once HIV has entered the body, it attacks immune cells called CD4 cells. CD4 cells are a type of T cell, white blood cells that play a central role in immune response.

As CD4 cell count drops, an individual’s ability to fight off infection lessens.

The most serious cases of HIV, those that go untreated, may reach what could be called the third stage of infection, acquired immune deficiency (AIDS). Once HIV infection reaches this stage, the immune system is permanently compromised and may be unable to fight off an increasing number of serious illnesses or infections.

HIV is now a very manageable condition, and those who receive treatment can usually expect to live to old age. AIDS, on the other hand, remains incurable and often takes the lives of those it affects. Efforts on treating the condition, it logically follows, are chiefly focused on the early detection and aggressive treatment of HIV.

About the Parallel Track

As the AIDS epidemic spiraled increasingly out of control in the 1980s, public support grew for a program that would allow HIV/AIDS patients to access drugs and therapies still under investigation by the Food and Drug Administration.

It took a long time to get one. It wasn’t until 1992 that the FDA introduced the Parallel Track program. The program was designed to give patients who might not otherwise be suitable for clinical trials access to drugs still being clinically investigated. The decision was based on the obvious mortality risk of HIV infection, paired with the low risk of side effects of the investigational drugs in question.

The program also acts as an administrative organ that works to expand the availability of drugs for treating HIV/AIDS.

Senator Cruz’s Letter

In his letter to the FDA, also signed by senators Rand Paul, Mike Braun, and Mike Lee, Ted Cruz encouraged the FDA to expand the Parallel Track policy to those living with other similarly devestating chronic conditions.

Specifically, Cruz counted those living with Alzheimer’s disease, various types of cancer, and amyotrophic lateral sclerosis (ALS) as among those who could potentially benefit from the expansion of the policy.

Cruz concluded his letter by “strongly [encouraging]” Commissioner Sharpless to act on the matter.

Do you think it should be easier to access investigational drugs if you suffer from a life threatening or chronic condition? Why? Share your thoughts with Patient Worthy!

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