How Google Is Trying to Protect Your Drug Supply

The Internet giant is working with the feds to address the growing problem of illegal online pharmacies.

Picture taken on January 15, 2012 in Lille, northern France, of drug capsules.
National Journal
Sophie Novack
March 5, 2014, 6:07 a.m.

The up­side of on­line shop­ping is that it puts the In­ter­net’s full se­lec­tion at your fin­ger­tips. The down­side is that it’s harder to know ex­actly what you’re buy­ing. When it comes to buy­ing medi­cine, that down­side can be deadly.

Il­leg­al on­line phar­ma­cies are a par­tic­u­larly dan­ger­ous and elu­sive sec­tor of the grow­ing prob­lem of coun­ter­feit drugs. The scope of the In­ter­net com­pounds the rap­id glob­al­iz­a­tion of the drug sup­ply chain and its in­creas­ingly dan­ger­ous mis­use, mak­ing il­leg­al sellers more dif­fi­cult to trace.

As a res­ult, ma­jor In­ter­net play­ers — in­clud­ing Google — are work­ing with the fed­er­al gov­ern­ment to battle the prob­lem. Aim­ing to pin­point and veri­fy every al­leged on­line phar­macy is near-im­possible, so the fo­cus is in­stead on lim­it­ing their use through con­sumer edu­ca­tion, re­strict­ing their ap­pear­ance in In­ter­net searches, and en­for­cing harsh­er pun­ish­ment.

Cur­rently, 35,000 to 50,000 act­ive In­ter­net phar­ma­cies are be­lieved to be op­er­at­ing, and 97 per­cent of those sur­veyed do not meet U.S. stand­ards, ac­cord­ing to a 2013 re­port from the Na­tion­al As­so­ci­ation of Boards of Phar­macy. This could mean they are not ap­proved by the FDA, or tht their phar­macists are not li­censed by the state li­cens­ing board.

Coun­ter­feit drugs are of­ten pro­duced in un­san­it­ary con­di­tions, and they may in­clude none of the act­ive phar­ma­ceut­ic­al in­gredi­ent, in­cor­rect dosages, in­cor­rect in­gredi­ents, and even pois­ons. The dif­fer­ence in com­pos­i­tion can cause harm or death in un­know­ing con­sumers.

The Food and Drug Ad­min­is­tra­tion Safety and In­nov­a­tion Act passed in 2012 and the Drug Qual­ity and Se­cur­ity Act of 2013 in­clude guid­ance re­gard­ing safety of the le­git­im­ate drug sup­ply chain. Both laws are in the pro­cess of be­ing im­ple­men­ted, and they in­volve tight­er track and trace se­cur­ity as drugs travel between man­u­fac­turer and pa­tient.

Yet reg­u­lat­ing In­ter­net phar­ma­cies can be more chal­len­ging be­cause they sell dir­ectly to con­sumers, and it can be nearly im­possible for pa­tients to know wheth­er a web­site — and the drug it is selling — is le­git­im­ate.

“There is no one easy bul­let or easy solu­tion,” Bruce Long­bot­tom, as­sist­ant gen­er­al coun­sel for Eli Lilly, said at a House En­ergy and Com­merce Com­mit­tee hear­ing last week. He sug­gests pa­tient edu­ca­tion, stronger laws, great­er en­force­ment of ex­ist­ing laws, and co­ordin­a­tion with In­ter­net com­pan­ies as steps in the right dir­ec­tion.

The glob­al nature of the drug sup­ply chain makes over­sight more dif­fi­cult, both on­line and on the ground. About 40 per­cent of drugs taken in the U.S. are from over­seas, and 80 per­cent of phar­ma­ceut­ic­al in­gredi­ents are made in for­eign coun­tries. At the same time, FDA over­sight in­ter­na­tion­ally is even more lim­ited than with­in the U.S. Ac­cord­ing to the Gov­ern­ment Ac­count­ab­il­ity Of­fice, the FDA is able to in­spect do­mest­ic drug fa­cil­it­ies only every two years, and for­eign plants just every nine years.

Google, in par­tic­u­lar, does not have a clean re­cord in deal­ing with in­ter­na­tion­al on­line phar­ma­cies. The com­pany pre­vi­ously al­lowed Ca­na­dian sellers to ad­vert­ise through its Ad­Words pro­gram, tar­get­ing Amer­ic­an con­sumers and il­leg­ally im­port­ing drugs in­to the U.S. A set­tle­ment was reached in 2011, in which Google for­feited $500 mil­lion and agreed to a set of meas­ures to en­sure re­port­ing of coun­ter­feit drug sales to the fed­er­al gov­ern­ment.

Google is now a mem­ber of the Cen­ter for Safe In­ter­net Phar­ma­cies, a non­profit formed in 2011 with the mis­sion of pro­mot­ing se­cure on­line phar­ma­cies through “edu­ca­tion, en­force­ment, and in­form­a­tion shar­ing.” This in­volves both lim­it­ing the vis­ib­il­ity and ac­cess­ib­il­ity of rogue sellers, and edu­cat­ing con­sumers about identi­fy­ing safe on­line phar­ma­cies.

Oth­er CSIP mem­bers in­clude Mi­crosoft, Face­book, Ya­hoo, Visa, Amer­ic­an Ex­press, UPS, and more. The group aims to part­ner with gov­ern­ment of­fi­cials, health pro­viders, law en­force­ment, and oth­er groups to edu­cate pa­tients about find­ing safe medi­cine on­line; aid law en­force­ment ef­forts; and cre­ate a pub­lic list of safe web­sites for con­sumers.

In­ter­net com­pan­ies are work­ing to re­port and re­move il­leg­al phar­ma­cies from In­ter­net search res­ults, while pay­ment net­works aim to pre­vent pay­ment trans­ac­tions for il­leg­al drugs.

Ac­cord­ing to the CSIP web­site, the co­ali­tion par­ti­cip­ated in “Op­er­a­tion Pangea” with the FDA in Novem­ber 2012, shut­ting down more than 18,000 il­leg­al phar­macy web­sites and con­fis­cat­ing $10.5 mil­lion worth of pills. Since 2011, Google has re­moved more than 3 mil­lion ad­vert­ise­ments and made thou­sands of re­fer­rals to law en­force­ment.

An­oth­er piece of ad­dress­ing the prob­lem is try­ing to de­ter coun­ter­feit­ers from selling their drugs in the first place, which many agree re­quires harsh­er pun­ish­ments.

Drug coun­ter­feit­ing cur­rently has a high fin­an­cial in­cent­ive and re­l­at­ively low risk. The in­dustry gen­er­ated an es­tim­ated $75 bil­lion in 2010, ac­cord­ing to a study from the Cen­ter for Medi­cine in the Pub­lic In­terest. Coun­ter­feit­ing drugs is con­sidered far more luc­rat­ive than coun­ter­feit­ing cash.

Yet pen­al­ties are lim­ited, and those un­der FDASIA do not ap­ply to trans­ac­tions out­side the le­git­im­ate drug sup­ply chain. Cur­rently, selling for­eign un­ap­proved drugs is only a mis­de­mean­or, ac­cord­ing to Howard Sk­lam­berg, deputy com­mis­sion­er for Glob­al Reg­u­lat­ory Op­er­a­tions and Policy at the FDA. Pun­ish­ment in­creases if the gov­ern­ment is able to prove fraud, but the max­im­um sen­tence for selling coun­ter­feit drugs is three years in pris­on, or $10,000.

Con­trolling coun­ter­feit drugs is an un­usu­al bi­par­tis­an is­sue in the cur­rent health policy cli­mate.

“I’m pleased we are hav­ing an im­port­ant over­sight hear­ing where 20 minutes in­to the hear­ing no one has blamed the prob­lem on Pres­id­ent Obama,” said Rep. Wax­man, D-Cal­if., at the E&C hear­ing. “That’s rare for this com­mit­tee.”

The co­oper­a­tion is cru­cial be­cause the is­sue of il­leg­al on­line phar­ma­cies is so com­plex and daunt­ing. Even with the col­lab­or­a­tion of the gov­ern­ment, In­ter­net pro­viders, phar­ma­ceut­ic­al com­pan­ies, and oth­er stake­hold­ers, con­trolling the grow­ing prob­lem of coun­ter­feit drug sales re­mains a con­stant chal­lenge.

“You have an agree­ment with Google about on­line phar­ma­cies?” Re­pub­lic­an Rep. Mi­chael Bur­gess of Texas asked Sk­lam­berg at the hear­ing. “Be­cause — I don’t want to speak out of school — ut I just typed ‘cheap Via­gra’ in­to Google, and you get a lot of sites…. I’m not sure that’s work­ing all that well. You might want to check it out.”

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