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.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

House Committee on Oversight and Reform Chairwoman Carolyn Maloney (Getty Images)

House De­moc­rats call on Emer­gent ex­ecs to tes­ti­fy on qual­i­ty is­sues next month

The House Oversight Committee is investigating Covid-19 vaccine producer Emergent BioSolutions, which secured a $628 million US government contract to make AstraZeneca and J&J vaccines despite “a long, documented history” of quality control issues, Democrats said in a letter to the contract manufacturer’s executives.

Emergent’s Baltimore plant, which was shuttered on Monday by FDA, has been embroiled in controversy after being forced to destroy millions of AstraZeneca and J&J doses due to an ingredient mix-up and possible contamination.

Emma Walmsley, GlaxoSmithKline CEO (Kevin Dietsch/Pool via CNP/Alamy)

Glax­o­SmithK­line hus­tles the 7th PD-1 past the fin­ish line with Jem­per­li. But how big will up­take be?

Everything came up sevens for GlaxoSmithKline on Thursday as the pharma notched the seventh PD-1 approval seven years after the first such drugs were OK’ed in Keytruda and Opdivo. But will it bring GSK good fortune?

The FDA granted accelerated approval to dostarlimab, to be branded Jemperli, to treat recurrent or advanced endometrial cancer in a specific subset of patients following platinum-based chemo. It’s a drug that came to GSK through its buyout of Tesaro, which it snapped up for $5.1 billion back in December 2018.

Why re­mote drug man­u­fac­tur­ing eval­u­a­tions won't re­al­ly re­duce FDA's back­log of in­spec­tions

For the first several months of the pandemic last spring, the FDA continued to plow through its user fee-enabled work on new drug and biologic applications, meeting nearly all of its goal dates.

But by last fall and into the winter, complete response letters and other delays began arriving in companies’ mailboxes as the agency struggled to catch up to a growing backlog of both domestic and foreign drug manufacturing inspections.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.