FDA says vol­ume man­u­fac­tur­ing dead­line is not a re­quire­ment af­ter drug­mak­ers lash out

Back in Oc­to­ber, the FDA re­leased a con­tro­ver­sial draft guid­ance ex­plain­ing to drug man­u­fac­tur­ers how, be­gin­ning on Feb. 15, 2022, the FDA would start col­lect­ing an­nu­al man­u­fac­tur­ing re­ports.

It would start with 2020 man­u­fac­tur­ing da­ta, in­clud­ing the vol­ume or amount of each drug, and the same for ac­tive phar­ma­ceu­ti­cal in­gre­di­ents.

The re­ports were cre­at­ed as part of the CARES Act, en­act­ed in May 2020, which aid­ed the Covid-19 re­sponse fund­ing and added new pro­vi­sions, like this one, meant to ad­dress pan­dem­ic-ex­ac­er­bat­ed drug short­ages, by im­prov­ing FDA’s vis­i­bil­i­ty in­to drug/API sup­ply chains.

Drug­mak­ers al­most uni­form­ly called for a de­lay in the time­lines of these vol­ume re­ports, not­ing they would need more time to set up sys­tems to track this re­quest­ed in­fo and not­ing that ear­li­er years’ da­ta might mis­lead­ing­ly sug­gest short­ages that no longer ex­ist.

In­dus­try group BIO in­quired in­to how the FDA might use this new da­ta, and how it will en­force the re­port­ing re­quire­ment, and which penal­ties, if any, would be im­posed on es­tab­lish­ments that do not re­port on the quan­ti­ty of a drug in­tend­ed for com­mer­cial dis­tri­b­u­tion.

“With over 275,000 fin­ished and un­fin­ished drug pack­age ND­Cs, ac­cord­ing to FDA’s NDC di­rec­to­ry, the Agency is ask­ing in­dus­try to com­pile, for­mat, and sub­mit over 3.3 mil­lion da­ta points to the Agency in less than four months af­ter is­suance of the draft guid­ance,” gener­ic drug­mak­er Vi­a­tris said in its com­ment.

Pfiz­er al­so raised con­cerns with FDA that the guid­ance is­sued may cre­ate prob­lems for com­pa­nies that have con­fi­den­tial­i­ty agree­ments with their con­tract man­u­fac­tur­ers.

“Pro­vid­ing re­ports as re­quired un­der sec­tion 510(j)(3) could be con­sid­ered a breach of these agree­ments and may be im­pact­ful to the CMO busi­ness,” Pfiz­er wrote.

While the draft guid­ance said that re­ports for 2020 should be sub­mit­ted by this past Tues­day, and that re­ports for 2021 should be sub­mit­ted by mid-May, the agency now says those aren’t hard dead­lines.

In a rare note, re­leased the day be­fore the first dead­line, the FDA sig­naled that it heard in­dus­try’s ques­tions loud and clear, and that this first Feb. 15 dead­line is not ac­tu­al­ly a re­quire­ment. FDA ex­plains:

FDA is con­sid­er­ing com­ments to our draft guid­ance on Re­port­ing Amount of List­ed Drugs and Bi­o­log­i­cal Prod­ucts Un­der Sec­tion 510(j)(3) of the Fed­er­al Food, Drug, and Cos­met­ic Act, in­clud­ing com­ments about the rec­om­mend­ed time­lines for sub­mit­ting the re­quired re­ports. The draft guid­ance doc­u­ment is not a bind­ing doc­u­ment, and the rec­om­mend­ed Feb­ru­ary 15, 2022 re­port­ing date for 2020 da­ta is not a re­quire­ment. We are care­ful­ly re­view­ing all is­sues raised by stake­hold­er com­ments to the dock­et, in­clud­ing re­gard­ing the rec­om­mend­ed re­port­ing time­frames. We will con­sid­er up­dat­ing the draft guid­ance’s rec­om­mend­ed time­frames for re­port­ing, as ap­pro­pri­ate, along with oth­er is­sues raised by such stake­hold­er feed­back.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

Bags of shred­ded docs: In­di­an drug­mak­er Lupin hand­ed a Form 483 by FDA in­spec­tors

The generics manufacturer Lupin has been given another Form 483 from the FDA this year.

US regulators inspected Lupin’s pharmaceutical manufacturing site in the town of Mandideep, India from Nov. 14 through Nov. 23, with the 14-page report marking 16 observations.

The inspection report stated that the site did not have the appropriate controls over its computer systems to ensure that changes in “master production” or records are only done by authorized personnel, along with written procedures not being established to conduct annual reviews of records associated with drug batches.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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FDA re­view­ers head back to White Oak in 2023, with lead­er­ship look­ing to ap­pease a new Con­gress

Republicans have taken a stand against the pandemic era habit of lax work-from-home schedules. Now that they’ve wrestled control of the House majority, the FDA’s leadership is playing ball, sending many of the agency’s more than 18,000 employees back to their desks early next year.

Whether this exodus back to White Oak in Silver Spring, MD (many staff will still be allowed to work from home for multiple days per week) will mean more defections to industry and elsewhere remains to be seen.

Bro­ken promis­es? FDA needs more pow­er to re­move drugs from mar­ket­place, JA­MA analy­sis finds

The FDA is struggling to remove drugs from the marketplace that don’t show effectiveness in late stage trials, new JAMA analyses found, thanks to the persistent tension between speed and confidence in early clinical data.

Congress, regulated industry and patients have urged the FDA to shorten the amount of time that the market has to wait for drugs to become available that may help severe and prevalent diseases – and the FDA has listened, offering up a quick accelerated approval pathway that’s frequently used by new cancer drugs.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.