Research & Commentary: Drug Approval Reform Popular and Long-Overdue

Published May 10, 2019

For decades, government intervention into the health care sector has increased at the expense of individual freedom. This disturbing trend is especially prevalent when it comes to the antiquated drug approval process.

To the dismay of many Americans, it typically takes 12 years and $3 billion to get a drug from lab to market. Even worse, Americans with terminal illnesses and chronic diseases are not allowed to access potentially lifesaving medications because the U.S. Food and Drug Administration (FDA), the agency in charge of drug approval, is a bureaucratic leviathan wrapped in red tape.

In short, every year far too many Americans unnecessarily suffer or even die waiting for potentially lifesaving treatment because the FDA approval process moves so slowly.

The North Carolina legislature has made a positive step to broaden the scope and expand the current Right to Try law to include other categories of patients. House Bill 934 would cast a larger net allowing more patients access to potentially lifesaving treatment, but still doesn’t address the root of the problem: the antiquated drug approval process. It still takes 12 years and 3 billion dollars to get a drug from lab to market. Too many patients are waiting and dying while the FDA bureaucracy churns93 percent of American voters support FDA making “prescription drugs better, available sooner, and at a lower cost.” In general, Right to Try and H.B. 934 are steps in the right direction.

However, a more comprehensive solution to this problem would be the expansion of a parallel track system. In the 1992, a parallel track was created during the height of the AIDS epidemic. Fortunately, this provided access to lifesaving treatments for more than 12,000 AIDS patients.

Clearly, there is an urgent need for FDA reform. Indeed, 95 percent of Americans across the political spectrum support patients and their doctors making health care decisions—not the federal government.

To achieve this scenario, Heartland proposes a structural reform that would allow patients with debilitating diseases, which would include terminal and chronically ill patients, to access medication on the Free to Choose Medicine Track (FTCMT). This is an alternative to the status quo clinical trial process that is lengthy, costly, and convoluted. 

FTCMT would allow drug manufacturers to put treatments on an independent track in addition to the current FDA clinical trial process. Under FTCMT, treatments that have passed FDA stage one safety trials and at least one stage two efficacy test could be available to patients. The transformative nature of modern medicine is evolving at lightning speed. Technology is revolutionizing the process of diagnosis and cures. Unfortunately, the outdated FDA drug approval process is not compatible with (and often stifles) the miracles modern medicine has to offer.

In addition to creating a Free to Choose Medicine Track, Heartland supports a Trade-off-Evaluation-Drug-Database, wherein patient data could be used with current clinical trials to enhance the drug development process. This database would allow real world data to be used for observational approval of drugs that otherwise would take more than a decade to approve.

The Free to Choose Medicine Track is not a Band-Aid solution. Rather, it addresses the root of the problem that is poisoning the American health care system: rigid rules that prevent patients from accessing treatments that could save their lives.


An FDA Report Card: Wide Variance in Performance Found Among Agency’s Drug Review
Report by the Manhattan Institute analyzes the performance of FDA agencies.  The United States Food and Drug Administration (FDA) reviews and must ultimately approve any new drug as “safe and effective” before it can be marketed for sale in the United States. The question of whether the agency is too cautious in its reviews (delaying access to critically needed treatments), or too fast in issuing approvals (potentially exposing patients to undetected risks from new products), has long been a subject of public debate.

Policy Brief: A Modern System for Approving the Cures of the Future
Policy brief by The Heartland Institute argues an FTCM approach, by collecting real-world data on the effects of new drugs, would provide more patients with access to potentially life-saving drugs, and it would do so much faster and more efficiently than the current FDA system

Policy Brief: How Extending the AIDS Drug Access Model to Other Diseases Would Save Lives
Policy brief by The Heartland Institute will outline the need to speed up treatments and cures for these and other diseases, which is as critical now as the need to facilitate the development and delivery of medications for AIDS/HIV sufferers was three decades ago.

The Heartland Institute 2019 National Survey of Voters on Health Care Issues
A poll commissioned by The Heartland Institute, found that 92.8% of voters support the U.S. Food and Drug Administration (FDA) making “prescription drugs better, available sooner, and at a lower cost.” The poll was conducted by Victory Enterprises from February 11-14, 2019 of 500 voters – defined as those who voted in the last election and plan to vote in the next election. The margin of error for this scientific nationwide survey is +/- 4.38%.


Nothing in this Research & Commentary is intended to influence the passage of legislation, and it does not necessarily represent the views of The Heartland Institute. For further information on this subject, visit The Heartland Institute’s website, and PolicyBot, Heartland’s free online research database.

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