Four former FDA com­mis­sion­ers: Im­ported drugs could harm con­sumers

The Washington Post Sunday - - POLITICS & THE NATION - BY LAURIE MCGINLEY laurie.mcginley@wash­

The four most re­cent Food and Drug Ad­min­is­tra­tion com­mis­sion­ers are warn­ing Congress that le­gal­iz­ing the im­por­ta­tion of drugs from other coun­tries — an idea that has drawn sup­port from both Bernie San­ders and Don­ald Trump — would en­dan­ger con­sumers by ex­pos­ing them to fake, sub­stan­dard and con­tam­i­nated drugs.

The open let­ter to mem­bers of Congress, which was posted Fri­day by the Mar­go­lis Cen­ter for Health Pol­icy at Duke Univer­sity, was signed by two former FDA heads who served dur­ing the Obama ad­min­is­tra­tion — Robert Califf and Mar­garet Ham­burg — and two who served un­der Ge­orge W. Bush — An­drew von Eschen­bach and Mark McClel­lan.

While ac­knowl­edg­ing that drug im­por­ta­tion is de­signed to give Amer­i­cans ac­cess to less-ex­pen­sive medicines, it also would prob­a­bly “harm pa­tients and con­sumers and com­pro­mise the care­fully con­structed sys­tem that guards the safety of our na­tion’s med­i­cal prod­ucts,” they write.

Last month, San­ders, the in­de­pen­dent sen­a­tor from Ver­mont, and sev­eral Democrats in­tro­duced leg­is­la­tion in the Se­nate and House to al­low the im­por­ta­tion of drugs, first from li­censed sell­ers in Canada and later pos­si­bly from Europe. Med­i­ca­tions in many coun­tries are cheaper than in the United States be­cause of gov­ern­ment price con­trols.

How­ever, the former FDA lead­ers warn in their let­ter that “global ex­pe­ri­ence con­firms that il­licit, in­ef­fec­tive, or adul­ter­ated prod­ucts are read­ily avail­able on the open mar­ket and rep­re­sent one of the most lu­cra­tive av­enues of or­ga­nized crime.”

In an in­ter­view Fri­day, Califf said the vast ma­jor­ity of web­sites that ad­ver­tise as be­ing Cana­dian are ac­tu­ally based in South Amer­ica, Eastern Europe or Rus­sia. Con­sumers have no re­li­able way of know­ing where the drugs ac­tu­ally come from or what’s in them, he said. Nor can re­cip­i­ents be sure they’re get­ting what they or­dered.

“What if you think you are tak­ing a statin, but you aren’t?” he asked, re­fer­ring to med­i­ca­tion to con­trol choles­terol. “You wouldn’t feel any dif­fer­ent . . . . And what if you were 70, with six med­i­cal prob­lems be­ing treated with 10 drugs, and you got sick and died. Who would know?”

Sup­port­ers of drug im­por­ta­tion pooh-pooh many of the safety con­cerns, say­ing that they can be man­aged and that the drug in­dus­try is ex­ag­ger­at­ing the risk to thwart change. They note that the San­ders bill man­dates that drugs be im­ported only from FDA-cer­ti­fied sell­ers and re­quires the agency to in­spect man­u­fac­tur­ing fa­cil­i­ties that pro­duce drugs for ex­port to the United States.

Some took is­sue with the com­mis­sion­ers’ let­ter. “The In­ter­net has been a life­line of af­ford­able medicines, im­ported for per­sonal use by us­ing safe in­ter­na­tional on­line phar­ma­cies that re­quire valid pre­scrip­tions,” said Gabriel Le­vitt, pres­i­dent of Phar­ma­, which ver­i­fies the cre­den­tials of over­seas phar­ma­cies. He pointed to a Kaiser Fam­ily Foun­da­tion study that found that 19 mil­lion Amer­i­cans have bought im­ported drugs, in­clud­ing through the In­ter­net.

San­ders, who has or­ga­nized bus trips with his con­stituents to buy drugs in Canada, con­tends that if the gov­ern­ment can en­sure the safety of im­ported food, it can also en­sure the safety of im­ported drugs. “There is no ar­gu­ment,” he said at a re­cent news con­fer­ence. “The drugs that come into this coun­try must be 100 per­cent safe, and we will do that. We will not tol­er­ate rogue out­fits.”

Dur­ing his cam­paign, Trump said con­sumers should be al­lowed to im­port drugs from over­seas. As pres­i­dent, how­ever, he hasn’t pur­sued the sub­ject.

In the former FDA com­mis­sion­ers’ let­ter, they ex­pressed skep­ti­cism that the agency would ever be given enough re­sources by Congress to po­lice im­ported drugs. “Ob­tain­ing suf­fi­cient re­sources and ex­per­tise to screen and ver­ify the au­then­tic­ity of ev­ery prod­uct des­tined for Amer­i­can con­sumers presents enor­mous chal­lenges,” they wrote.

Scott Got­tlieb, a physi­cian who the White House re­cently an­nounced would be nom­i­nated to lead the FDA, agrees with his pre­de­ces­sors. He said in a March 2016 ar­ti­cle in Forbes that im­por­ta­tion wouldn’t achieve its aim of pro­vid­ing cheaper drugs but would pose significant cost and safety is­sues.

Phar­ma­ceu­ti­cal com­pa­nies will not “sim­ply ramp up the pro­duc­tion lines to ac­com­mo­date new de­mand if it means that the drugs will be im­ported into the U.S. to skirt their tiered pric­ing,” he said. “Nor will the for­eign coun­tries al­low their lo­cal sup­ply to be skimmed off only to cre­ate lo­cal short­ages of im­por­tant medicines.”

Putting in an ad­e­quate FDA reg­u­la­tory sys­tem for drug im­ports would be pro­hib­i­tively ex­pen­sive, he added.

“I worked on sketch­ing an im­por­ta­tion scheme for the FDA reg­u­la­tion of im­ported drugs when it looked like sim­i­lar leg­is­la­tion would pass in 2004,” noted Got­tlieb, a former of­fi­cial both there and at the Cen­ters for Medi­care and Med­i­caid Ser­vices. “That scheme would have added so much cost to the im­ported drugs, they wouldn’t be much cheaper than drugs sold in­side our closed Amer­i­can sys­tem.”

Al­though cur­rent law bans the im­por­ta­tion of drugs, the FDA usu­ally looks the other way when peo­ple bring small amounts back from Cana­dian phar­ma­cies for their per­sonal use. That’s be­cause it’s the In­ter­net phar­ma­cies, not the brickand-mor­tar Cana­dian ones, that worry reg­u­la­tors, Califf said.

By con­trast, the “closed” U.S. drug dis­tri­bu­tion sys­tem, as over­seen by the FDA, en­sures good man­u­fac­tur­ing prac­tices and the qual­ity and se­cu­rity of an in­creas­ingly com­plex sup­ply chain, the let­ter notes.

More at wash­ing­ton­ blogs/to-your-health

“Drugs that come into this coun­try must be 100 per­cent safe, and we will do that. We will not tol­er­ate rogue out­fits.” Sen. Bernie San­ders (I-Vt.)

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