FDA looks at over­seas tri­als

FDA sends staff over­seas to help mon­i­tor imports

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In re­cent years, drug and de­vice com­pa­nies have started to oper­ate more clin­i­cal tri­als in South Amer­ica, which re­flects the grow­ing num­ber of clin­i­cal trial sub­jects and sites lo­cated out­side of the U.S. As Amer­i­can com­pa­nies seek a more cost­ef­fec­tive environment and larger pools of pa­tients, weigh­ing the clin­i­cal data gath­ered at tri­als out­side of the U.S. is one ex­am­ple of how glob­al­iza­tion has af­fected the re­spon­si­bil­i­ties of the Food and Drug Ad­min­is­tra­tion.

Up to 65% of clin­i­cal tri­als for FDA-reg­u­lated prod­ucts oc­curred out­side of the U.S. in 2008, ac­cord­ing to a 2010 re­port from HHS’ in­spec­tor gen­eral’s of­fice. The FDA has re­ported that reg­u­lated prod­ucts now make up about one-tenth of all imports into the U.S.

While the is­sue of how the fed­eral agency reg­u­lates an in­creas­ingly global mar­ket is not new, the re­lease of the Path­way to Global Prod­uct Safety and Qual­ity re­port in July sig­naled a shift in how the FDA plans to ad­dress grow­ing con­cern about coun­ter­feit or adul­ter­ated drugs and an in­creas­ingly com­plex global sup­ply chain.

“It’s still a do­mes­tic mis­sion,” says Dr. Murray Lump­kin, the FDA’s deputy com­mis­sioner for in­ter­na­tional pro­grams. “What has changed fun­da­men­tally is the ever-in­creas­ing num­ber of prod­ucts that we are see­ing from over­seas.”

The FDA be­gan post­ing staff po­si­tions out­side of the U.S. in 2008, ac­cord­ing to Lump­kin, and cur­rently has 50 per­ma­nent em­ploy­ees based out­side of the U.S., in­clud­ing 33 U.S. cit­i­zens and 17 lo­cally em­ployed sup­port staff.

Twenty of those 33 FDA po­si­tions are lo­cated in China and In­dia. Ac­cord­ing to the FDA re­port, med­i­cal prod­uct exports from these two coun­tries are ex­pected to in­crease by more than 400% over the next decade. A Pew Health Group re­port about sub­stan­dard and coun­ter­feit drugs found that raw phar­ma­ceu­ti­cal ma­te­ri­als, in­clud­ing ma­te­ri­als used to man­u­fac­ture older and off-patent drugs, ex­ported to the U.S. from China is now a $2.2 bil­lion busi­ness.

In con­trast, FDA op­er­a­tions in Bel­gium, Chile, Eng­land, Italy, Jor­dan and South Africa are each staffed by one em­ployee.

Work­ing to­gether

Lump­kin says the over­seas FDA em­ploy­ees—only a small por­tion are in­spec­tors—work closely with ex­porters, as well as with other fed­eral agen­cies such as the Agri­cul­ture and Jus­tice de­part­ments and Cus­toms and Bor­der Pro­tec­tion. In­spec­tion is a small part of what FDA staff is re­spon­si­ble for over­seas, he says. Other tasks in­clude mon­i­tor­ing the lo­cal reg­u­la­tory and po­lit­i­cal arena, en­vi­ron­men­tal scan­ning, gath­er­ing in­for­ma­tion to in­form de­ci­sions to al­low prod­ucts into the U.S., and in­ter­act­ing with coun­ter­part agen­cies within the re­gion.

Glob­al­iza­tion also has led to changes in how com­pa­nies oper­ate. Over the past cou­ple of years, U.S.-based com­pa­nies that oper­ate man­u­fac­tur­ing fa­cil­i­ties abroad or buy raw ma­te­ri­als from ven­dors out­side of the U.S. have started to place em­ploy­ees in for­eign plants for lim­ited or ex­tended pe­ri­ods of time, says Linda Bent­ley, a lawyer with Mintz, Levin, Cohn, Fer­ris, Glovsky and Popeo in Bos­ton and chair of the firm’s FDA prac­tice.

In those cases, em­ploy­ees sup­port qual­ity ef­forts by con­duct­ing in­spec­tions and test­ing prod­ucts, rather than solely re­ly­ing on a cer­tifi­cate of anal­y­sis, a doc­u­ment pro­vided by a sup­plier that cer­ti­fies the ma­te­ri­als.

U.S.-based com­pa­nies are in­creas­ingly seek­ing to cut costs by out­sourc­ing the pur­chase of raw ma­te­ri­als and man­u­fac­tur­ing to emerg­ing mar­kets. Ac­cord­ing to the FDA, the cost of for­mu­la­tion of an ac­tive phar­ma­ceu­ti­cal in­gre­di­ent can cost up to 40% less in In­dia com­pared with the same in­gre­di­ent in the U.S.

“Amer­i­can man­u­fac­tur­ers are look­ing over­seas for less ex­pen­sive sources of prod­ucts,” Bent­ley says. “The pri­mary driv­ing force is the price and busi­ness con­sol­i­da­tion.”

While U.S.-based com­pa­nies have longestab­lished man­u­fac­tur­ing and re­search and de­vel­op­ment fa­cil­i­ties over­seas, re­duc­ing costs and in­creas­ing pro­duc­tiv­ity re­main pri­or­i­ties.

Some drugs and de­vices made in Ire­land— which has served as an en­try point for Amer­i­can com­pa­nies in the Euro­pean Union for decades, in part be­cause there is no lan­guage bar­rier— are im­ported in the U.S., says Barry Heavey, vice pres­i­dent of , tech­nol­ogy mar­ket­ing for Ir­ish in­vest­ment pro­mo­tion agency IDA Ire­land. About 40 med­i­cal tech­nol­ogy com­pa­nies with head­quar­ters in the U.S. have man­u­fac­tur­ing fa­cil­i­ties in Ire­land, in­clud­ing Abbott Lab­o­ra­to­ries, Bax­ter, Bec­ton Dickinson & Co., and Medtronic, ac­cord­ing to IDA Ire­land.

“While a large por­tion of U.S. med­i­cal prod­uct imports have his­tor­i­cally come from Western Europe, there are in­di­ca­tions of a shift,” ac­cord­ing to the FDA re­port. “Im­port lines from emerg­ing mar­kets, in­clud­ing Mex­ico, In­dia, China and Thai­land in­creased faster be­tween 2002 and 2009 than lines from de­vel­oped mar­kets, and this dis­par­ity is likely to con­tinue.”

As more man­u­fac­tur­ers in emerg­ing mar­kets are ex­port­ing prod­ucts to the U.S. sub­ject to FDA reg­u­la­tion, the agency ar­gues that cre­at­ing a coali­tion of reg­u­la­tors from around the globe is needed to sup­port changes in the in­ter­na­tional trade of med­i­cal prod­ucts.

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