Citizensʼ Council for Health Freedom Media president Twila Brase says the current FDA drug approval process is too long and expensive.
“The expense has likely discouraged entrepreneurs from developing medications, especially for individuals with rare conditions. While some flexibility has occurred in recent years (Right to Try), the entire regulatory approval process is fraught with cost and timeliness issues,” Brase told the FDA Reporter.
Brase said she had a couple of ideas for FDA reform.
“What if FDA were to let developers develop medications, and instead of giving approval at the outset, come in after the fact if a drug rose to a significant level of concern? There could be an FDA reporting mechanism for the public and for practitioners, and a post-market investigation of these products. The FDA could start with medications in a certain category as a pilot project,” Brase said.
“This proposal assumes that a multitude of patient injuries and deaths would be a media disaster for pharmaceutical companies, and that they would try to avoid such a disaster, and the likely lawsuits, by doing what they need to do to put a safe product on the market. As a company, they would determine how much testing, and what warnings, would be necessary to protect them from such a public relations and litigious disaster.”
Brase said under the present regulatory scheme, what miracle medications are never developed because no one is willing to take the financial risk of FDA approval?
“What lives are shortened or lost because few companies are willing to spend a decade or more going through the regulatory process? Which of them are willing to potentially lose the ability to sell the medication and recoup the costs simply because a group of FDA regulators decide they don’t like the product or claim the medication isn’t necessary due to other available and similar medications? We don’t do this with cars, or food, or homes, or phones or any other products,” Brase said.
Brase then asked the question how low could the price of medication go if all the costs of FDA approval disappeared?
“And how fierce would the competition be if many smaller competitors were allowed to engage on a level playing field with large corporations? What diseases and conditions could be cured if the FDA got out of the way and let innovative minds work at a pace not slowed by regulatory barriers?” Brase said. “I think we don’t know the answer to these questions. For the sake of patients, it might be interesting to open up the market to possibilities that aren’t possible today. We might experience pharmaceutical innovation at a pace and a price that we’ve never seen before.”
Brase summed it up this way.
“Too much regulation, or health plan/government limiting access to medications solely for tested conditions could limit very valuable off-label uses.”