This week, FDA Commissioner Scott Gottlieb said something revolutionary about the role of the FDA. For many years, the agency has maintained that its sole focus when it comes to regulating drugs is to ensure their safety and efficacy, but that drug prices are beyond its purview. In remarks pertaining to the FDA’s new initiative to speed up generic drug approvals of complex pharmaceuticals, Gottlieb stated that “if consumers are priced out of the drugs they need, that’s a public health concern that FDA should address.”
To those who support safe importation of lower-cost medications, that statement was the shot heard around the world. Indeed, drug prices are a public health concern. If we’re using logic, reason, and commonsense, it becomes untenable from a public policy and health perspective, grounded in basic medical ethics, to prohibit or even discourage importation of lawfully-manufactured medication by individuals who can’t afford it locally. (more…)
Yes. Last week, the four most recent commissioners of the U.S. Food and Drug Administration sent an open letter to Congress declaring that an importation bill, The Affordable and Safe Prescription Drug Importation Act, introduced by Senators Bernie Sanders, Cory Booker, and Bob Casey, if passed, would jeopardize consumer safety. The bill, as described here, provides for an extensive oversight role for the FDA to help individuals and pharmacies import lower cost medications from Canada.
Don’t get me wrong: the former FDA leaders make pertinent points about regulatory issues implicated in reforming our importation laws, which should be noted – and then used to implement new regulations to expand importation from Canada – not used to pretend safe importation is impossible.
Thankfully, when the Washington Post covered this last week, they included something I said to the reporter: “The Internet has been a lifeline of affordable medicines, imported for personal use by using safe international online pharmacies that require valid prescriptions…” And if I had more to say… (more…)
Too many Americans are being kept in the dark by the very governing authorities and companies that are meant to protect their health. The FDA goes too far in telling Americans not to buy lower cost medication from outside the country, and Big Pharma spends big money on media relations to generate stories about rogue online pharmacies that wrongly conflate them with safe international online pharmacies.