How to Speed Up the Drug Approval Process

Unless you are an asthma sufferer, you probably didn’t see the Food and Drug Administration’s (FDA) recent announcement that beginning next year it will ban the sale of  Primatene Mist, the only over-the-counter asthma inhaler sold in the United States.

Do new tests show that the drug is harmful or that there are unanticipated side effects? No. In fact, Primatene Mist has proven to be one of the most effective treatments for temporary asthma symptoms. Instead, the drug is being pulled for environmental reasons -- yes, you read that right. The only over-the-counter asthma treatment will no longer be available because of an international agreement created to stop the substances that damage the environment. Because Primatene Mist uses chlorofluorocarbons (CFCs) as a propellant (spray), the medicine is considered an atmospheric pollutant.

Not only is this a heavy-handed response by the feds, but it could actually be dangerous. Rather than put the needs of asthma sufferers first, this FDA action will require patients to pay more for alternative medical treatment and limit the likelihood that temporary asthma symptoms can be treated quickly and effectively.

For patients without medical insurance, this decision could likely lead to black-market purchases or an increased willingness to use stale-dated products. This is far more dangerous than the effects of the inhalers on the environment.

However, such decisions demonstrate that the FDA has gone far afield from its responsibility to ensure that efficacious drugs are efficiently approved for sale in the U.S. In fact, it really is time to consider reforms to the FDA like the Heartland Institute’s Free To Choose Medicine (FTCM) initiative.

How does Free To Choose Medicine work? FTCM makes an end run around the costly and time-consuming FDA reform approval process -- a process that in some instances is approaching 10 years. While providing modest safety protection, the longer approval times give little comfort to a patient with a terminal condition. In fact, there are literally hundreds of cases where a drug that would ultimately prove safe and effective was denied to patients -- and tragically, the patients died before getting access to the drug.

Free To Choose Medicine relies on a two-tiered system. One tier keeps the status quo for any who still believe it is useful or effective. A second tier relies on an innovative waiver approval process whereby patients with either a terminal diagnosis or a chronic illness are allowed to access drugs that have already been submitted to the FDA -- well before their formal approval would occur in the first tier.