FDA About to Make Drug Approvals More Difficult

For drug producers trying to bring their lifesaving treatments to market, sky-high approval costs are a formidable, and sometimes unbeatable, foe. The cost of creating a new medication and getting it approved tops an astounding $5 billion. And now, the Food and Drug Administration (FDA) is poised to make it more difficult to get cancer medications approved. The agency is proposing to subject cancer drugs to costlier and lengthier pre-approval trials, even if there’s promising preliminary evidence that these therapeutics shrink tumors. It’s unclear if drug sponsors will even be able to recruit enough volunteers needed to run a fully randomized clinical trial, given the rarity of cancer types being treated. Policymakers and FDA officials must recognize the changing landscape of therapeutics testing.  It’s critical that patients have access to game-changing medications without red tape and regulatory delay.