PhRMA at­tacks New Mex­i­co’s ‘short on de­tail’ plan for Cana­di­an drug im­ports

In­dus­try group PhRMA con­tin­ues to fight a Trump-era fi­nal rule to al­low drug im­ports from Cana­da as the lob­by­ing group has now pe­ti­tioned the FDA to re­ject New Mex­i­co’s im­port plan be­cause of miss­ing de­tails that may make the im­port­ed drugs un­safe and not cost-ef­fec­tive.

The ap­pli­ca­tion “pro­vides scant in­di­ca­tion that the pro­posed SIP [Sec­tion 804 Im­por­ta­tion Pro­gram] will lead to any—let alone sig­nif­i­cant—re­duc­tion in cost to con­sumers,” PhRMA said in its pe­ti­tion.

The in­dus­try lob­by­ing group called on the FDA to re­ject the ap­pli­ca­tion, not­ing that it’s in­com­plete be­cause it fails to iden­ti­fy a for­eign sell­er, im­porter, or FDA-reg­is­tered repack­ager or re­la­bel­er for the drugs to be im­port­ed, and it pro­vides on­ly a ten­ta­tive list of drugs.

“New Mex­i­co sub­mit­ted a pro­pos­al so short on de­tail that FDA can­not as­sess whether the safe­ty or cost cri­te­ria can be met,” PhRMA said.

The lob­by­ing group in Jan­u­ary al­so sought to block Flori­da’s drug im­port plan via an FDA pe­ti­tion, claim­ing it would “jeop­ar­dize pa­tient safe­ty.” And the group has filed a law­suit to stop the fi­nal rule, ex­plain­ing that it could ex­pose pa­tients to risks as­so­ci­at­ed with un­ap­proved, mis­brand­ed, and adul­ter­at­ed drugs.

“The Biden Ad­min­is­tra­tion has un­til the end of the month to re­spond to PhRMA’s com­plaint,” Rachel Sachs, pro­fes­sor of law at Wash­ing­ton Uni­ver­si­ty School of Law, ex­plained to End­points News. “But the rule hasn’t been en­joined – no court or­der is stop­ping the FDA from ap­prov­ing any sub­mit­ted plans. How­ev­er, the plans them­selves may not be suf­fi­cient to mer­it ap­proval. PhRMA’s com­ment on New Mex­i­co’s plan notes that the state has not iden­ti­fied a For­eign Sell­er – but the fi­nal rule ex­plic­it­ly per­mit­ted states to sub­mit pro­pos­als with­out do­ing so, giv­ing them six ad­di­tion­al months to iden­ti­fy a For­eign Sell­er, af­ter which the FDA could de­ny the pro­pos­al.”

Even with a for­eign sell­er, PhRMA al­so rais­es con­cerns about New Mex­i­co’s abil­i­ty to en­sure its plan saves mon­ey for con­sumers, not­ing that the ap­pli­ca­tion of­fers “on­ly the rough­est back-of-the-en­ve­lope math (based large­ly on spend­ing by health plans, not in­di­vid­ual con­sumers) to sup­port its claims that im­por­ta­tion would re­duce the cost of cov­ered prod­ucts to New Mex­i­co con­sumers.” For in­stance, the plan “ig­nores sub­stan­tial start-up and ad­min­is­tra­tive costs which will lim­it the State’s cost sav­ings or elim­i­nate any sav­ings en­tire­ly,” PhRMA says.

The ap­pli­ca­tion al­so of­fers on­ly a pre­lim­i­nary list of 40 drugs, in­clud­ing 7 to treat HIV/AIDS, and says that the state will con­duct two more rounds of re-as­sess­ments of drugs to un­der­stand whether op­er­a­tional con­sid­er­a­tions weigh against any of the im­ports.

“FDA can­not as­sess whether the safe­ty or cost cri­te­ria can plau­si­bly be met with­out know­ing the iden­ti­ty of piv­otal sup­ply chain par­tic­i­pants or the drugs to be im­port­ed,” PhRMA ex­plains.

The group al­so notes that the 7 HIV/AIDS drugs on the ini­tial list must be stored at a tem­per­a­ture that does not ex­ceed 30 de­grees Centi­grade. But New Mex­i­co’s ap­pli­ca­tion pro­vides “no guide­lines for en­sur­ing that each sup­ply chain par­tic­i­pant com­plies with the stor­age in­struc­tions in­clud­ed in each drug’s la­bel­ing.”

New Mex­i­co’s ap­pli­ca­tion con­cludes that con­sumers would save about $9.8 mil­lion per year (or $6 mil­lion if the HIV/AIDS drugs are ex­clud­ed) be­cause of the im­ports. But PhRMA notes that pay­ers and phar­ma­cy ben­e­fit man­agers “are not ob­lig­at­ed to re­duce pre­mi­ums or co­pay­ments in re­sponse to im­por­ta­tion, and thus there is no guar­an­tee that con­sumers will see any sav­ings at all.”

And PhRMA is not alone in its push to halt any drug im­ports from Cana­da be­fore the ship­ments start. Be­gin­ning late last No­vem­ber, Cana­da an­nounced that cer­tain drugs in­tend­ed for its mar­ket are now pro­hib­it­ed from be­ing dis­trib­uted for con­sump­tion out­side of Cana­da if that sale would cause or wors­en a drug short­age.

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