Deadly Regulatory SNAFU Hinders Effective Medical Treatment for Pain

The Centers for Disease Control and Prevention found that 64,000 people died from drug overdoses in 2016. Since 1999, the number of American overdose deaths involving opioids has quadrupled.

Now that president Trump has presented his plan to cut painkiller prescriptions by one-third, an obscure, “swamp-born” regulatory policy needs to be scrapped.

The regulation stipulates that before an old, previously approved generic medication or herbal remedy can be promoted for use to treat another illness, it has to go through an FDA approval process that costs an estimated $40-80 million. Because of this, no generic drug has ever been approved for a new indication, i.e., without modifying the drug’s delivery system or dose, which would provide renewed patent protection.1

“This is in spite of the fact that the medication or botanical has already been approved as safe in the past,” says board certified internist and pain expert Jacob Teitelbaum, MD. “Simply put, if a treatment is no longer patentable, it’s economically impossible to put through the regulatory process. It’s also illegal for any company with a potential financial gain to even discuss the research on these treatments,” he explains.

According to Dr. Teitelbaum, a regulatory “catch-22” of this kind should never be allowed to obstruct pain relief for millions. It also prevents any low-cost treatment from being approved in the U.S., with new treatments costing approximately 2.6 – $2.9 billion to go through the approval process. Although Congress meant for these laws to protect the public, they are instead contributing to well over 50,000 preventable deaths a year.

“It’s time for Congress to correct this deadly glitch in the regulatory system,” says Dr. Teitelbaum. “Simply allowing pharmaceutical and natural product companies to discuss research on effective treatments without running through a regulatory gauntlet that costs $80 million per treatment, could save tens of thousands of lives. It is time for this to happen – now!”

So what are your thoughts on this? Can you think of a better solution? What needs to be done?

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