The Food and Drug Administration aims to let only safe and effective drugs reach the US market \u2014 but its\u00a0turtle-speed approval process may be killing more patients than it protects. \u00a0<\/p>\n
FDA regulations have made long delays in clearing medical products the agency\u2019s norm.<\/p>\n
As far back as 1980, the great economist Milton Friedman was pointing to the FDA as Exhibit A in America\u2019s over-regulation problem.\u00a0<\/p>\n
It can take a decade or more to clear new medicines through the FDA\u2019s regulatory labyrinth, which requires companies to prove two things: that a drug is safe for patient use, and that it is an effective treatment for a particular ailment. \u00a0<\/p>\n
The latter is the stumbling block.<\/p>\n
Most of America\u2019s health-care spending \u2014 the 85% of it spent on medical procedures or other care, not pharmaceuticals \u2014 involves no bureaucratic\u00a0\u201chelp\u201d to determine efficaciousness.\u00a0<\/p>\n
Moreover, once the FDA approves a drug for one disease, doctors routinely prescribe it \u201coff label,\u201d without any government involvement, often finding that it\u2019s effective for other ailments<\/a> as well.\u00a0<\/p>\n So why can\u2019t the private sector do the same in the first place, once a drug has passed FDA-regulated safety trials?<\/p>\n Why must American patients wait years, suffering with and even dying of potentially curable illnesses, while bureaucrats put treatments through the evidentiary wringer?<\/p>\n It costs $2 billion or more to bring each successful\u00a0drug to market, given that about 90% of them must be abandoned during\u00a0the lengthy FDA process. \u00a0<\/p>\n The government\u2019s byzantine and unpredictable approval procedures thus divert billions of dollars of vital and scarce investment\u00a0capital away from drugs that could cure cancer, heart disease,\u00a0emphysema and other killer ailments. \u00a0<\/p>\n The two of us sometimes consult with drug companies to help them navigate the FDA maze \u2014 and we\u2019ve seen many promising drugs bottled up by the bureaucracy.<\/p>\n One of them shows great potential in slowing the\u00a0memory-loss progression of early-stage Alzheimer\u2019s.\u00a0There\u2019s currently no similar treatment, but the FDA wants to hold it back for many more years of effectiveness trials.\u00a0<\/p>\n The FDA is currently considering a drug for ataxia, a rare neurological\u00a0disease that often has agonizing effects. The drug\u00a0has been studied for more than eight years and is totally safe.<\/p>\n But anecdotal evidence of its\u00a0effectiveness from leading ataxia experts is not enough: The FDA is demanding lengthy\u00a0and expensive additional studies to prove it.\u00a0<\/p>\n Why deny a ray of hope to suffering patients?\u00a0 \u00a0<\/p>\n \t\t\t\t\t\t\tGet opinions and commentary from our columnists\t\t\t\t\t\t<\/p>\n \n\t\t\t\t\t\t\tSubscribe to our daily Post Opinion newsletter!\t\t\t\t\t\t<\/p>\n \t\t\t\t\t\tThanks for signing up!\n\t\t\t\t<\/p>\n Then there\u2019s Zynquista, a promising new drug for\u00a0patients with Type 1 diabetes.<\/p>\n It\u2019s the only\u00a0potential adjunct to insulin developed in over a century and is much less invasive \u2014 but the FDA has just\u00a0called for yet another round of trials that could cost millions of dollars, denying today\u2019s patients a chance\u00a0to better manage their disease. \u00a0\u00a0<\/p>\n President Donald Trump has been an enormous supporter of \u201cright to try\u201d orders<\/a>, which allow patients with life-threatening conditions to use drugs that have been shown not to have dangerous side effects.<\/p>\n But strict FDA regulations have thwarted Trump\u2019s effort: Insurance companies are reluctant to cover drugs that haven\u2019t checked the agency\u2019s efficacy boxes.<\/p>\n Instead, we need to relax or eliminate a 1962 law that required FDA to ensure effectiveness of drugs, not just their safety. \u00a0\u00a0\u00a0\u00a0\u00a0<\/p>\n