Andy Jassy, Amazon CEO (Isaac Brekken/AP Images for NFL, File)

Up­dat­ed: FDA slaps Ama­zon with a warn­ing let­ter for sell­ing OTC mole re­moval prod­ucts

The FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search on Tues­day re­leased a warn­ing let­ter sent last week to Ama­zon CEO Andy Jassy in Seat­tle for sell­ing mole re­moval prod­ucts over-the-counter, or, as the FDA ex­plains, “in­tro­duc­ing, de­liv­er­ing, or caus­ing the in­tro­duc­tion or de­liv­ery in­to in­ter­state com­merce of prod­ucts that are un­ap­proved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legal­ly sold for mole or skin tag re­moval, and FDA has safe­ty con­cerns about drugs mar­ket­ed OTC di­rect­ly to con­sumers for these us­es,” the agency said in its Aug. 4 warn­ing.

Cit­ing a Fed­er­al Reg­is­ter no­tice from 1990, the agency not­ed that its con­cerns are re­flect­ed in the OTC fi­nal mono­graph for wart re­mover drug prod­ucts (now a fi­nal ad­min­is­tra­tive or­der un­der sec­tion 505G of the FD&C Act), “which specif­i­cal­ly warns against the use of OTC top­i­cal wart re­mover prod­ucts on moles and birth­marks.”

FDA said it specif­i­cal­ly pur­chased two mole and skin tag re­mover prod­ucts via Ama­zon, “Deisana Skin Tag Re­mover, Mole Re­mover and Re­pair Gel Set” and “Skin­cell Mole Skin Tag Cor­rec­tor Serum,” which were de­liv­ered by Ama­zon.

The Seat­tle-based on­line shop­ping mar­ket has 15 days to re­spond, with the FDA adding, “If you be­lieve that the prod­ucts you dis­trib­ute are not in vi­o­la­tion of the FD&C Act, in­clude your rea­son­ing and any sup­port­ing in­for­ma­tion for our con­sid­er­a­tion.”

An Ama­zon spokesper­son told End­points, “Safe­ty is a top pri­or­i­ty at Ama­zon. We re­quire all prod­ucts of­fered in our store to com­ply with ap­plic­a­ble laws and reg­u­la­tions. The prod­ucts in ques­tion have been in­ves­ti­gat­ed and re­moved.”

The agency al­so sought to make clear that Ama­zon was the one that “in­tro­duced or de­liv­ered for in­tro­duc­tion in­to in­ter­state com­merce” the prod­ucts via its Ful­fill­ment by Ama­zon ser­vice.

“Ama­zon dis­trib­uted each of the prod­ucts di­rect­ly to in­di­vid­ual U.S. con­sumers on be­half of third par­ties. Each of the prod­ucts was ‘ful­filled’ by Ama­zon; your web­site states, ‘With Ful­fill­ment by Ama­zon (FBA), [sell­ers] store [their] prod­ucts in Ama­zon’s ful­fill­ment cen­ters, and [Ama­zon] pick[s], pack[s], ship[s], and pro­vide[s] cus­tomer ser­vice for these prod­ucts,'” the FDA writes.

The agency pre­vi­ous­ly warned Ama­zon last Ju­ly for dis­trib­ut­ing dozens of prod­ucts in­tend­ed for sex­u­al en­hance­ment and weight loss.

Ed­i­tor’s note: Ar­ti­cle up­dat­ed with Ama­zon com­ment.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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Richard Pazdur, FDA's OCE director (Flatiron Health via YouTube)

FDA's OCE makes the case for ac­cel­er­at­ed ap­proval rid­er in user fee reau­tho­riza­tion

Four experts from the FDA’s Oncology Center of Excellence took to the New England Journal of Medicine yesterday to make the case for not only improving the agency’s ability to expeditiously pull dangling accelerated approvals when, on the rare occasion, confirmatory trials fail, but also better building “quality and efficiency into the AA on-ramp.”

The timely perspective arrives as Congress has exactly one week left to draft, release and sign off on the reauthorized user fee deals before layoff notices will be sent to drug reviewers. That package, which is likely to hitch a ride with the continuing resolution, may or may not include several policy riders (opposed by Republicans), including one that would allow the FDA to require confirmatory trials to be underway before an AA is granted, and would improve the process by which FDA can withdraw AAs.

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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FDA ad­comm takes down Se­cu­ra Bio's leukemia drug af­ter fi­nal tri­al re­sults show po­ten­tial OS detri­ment

The FDA’s Oncologic Drugs Advisory Committee on Friday voted 8-4 against the benefit-risk profile of Secura Bio’s PI3K inhibitor Copiktra (duvelisib), which won approval in September 2018 as a third-line treatment for relapsed or refractory CLL or SLL, but updated pivotal trial results raised safety questions.

In addition to the serious and fatal toxicities of duvelisib, FDA speakers at the ODAC meeting pointed to an evolved treatment landscape for CLL and SLL, with targeted BTK or BCL2 inhibitors (front-line or second-line), and data pointing to a “potential detriment” in overall survival for duvelisib. But some ODAC members noted that the detriment was likely small and that there is some efficacy even as the data are difficult to interpret.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.