A House ap­pro­pri­a­tions sub­com­mit­tee ad­vanced via voice vote a new spend­ing bill for the FDA yes­ter­day, of­fer­ing $3.6 bil­lion in dis­cre­tionary fund­ing (i.e. not user fees), which is a 10% in­crease from this year and a $3 mil­lion in­crease over the agency’s re­quest.

Some of that in­crease, the com­mit­tee said, or $64 mil­lion will be di­rect­ed at the agency’s work on the opi­oid cri­sis, as CDC cit­ed over 100,000 over­dos­es in 2021, as well as med­ical sup­ply chain sur­veil­lance, drug safe­ty over­sight, and in­creas­ing and strength­en­ing in-per­son in­spec­tions of drug man­u­fac­tur­ers in In­dia, specif­i­cal­ly. The agency al­so will get $50 mil­lion in funds as part of the im­ple­men­ta­tion of the 21st Cen­tu­ry Cures Act.

Andy Har­ris

“Be­cause we rec­og­nize a dan­ger­ous gap and the need for more FDA in­spec­tion staff, we are en­sur­ing the FDA has the re­sources and per­son­nel to con­duct in­spec­tions and thor­ough­ly re­view in­fant for­mu­la ap­pli­ca­tion and man­u­fac­tur­ing con­tracts,” Rosa De­Lau­ro (D-CT), chair of the House ap­pro­pri­a­tions com­mit­tee, said yes­ter­day. “This bill builds on the ef­forts by this Com­mit­tee, through the House-passed sup­ple­men­tal ap­pro­pri­a­tion and the over­sight ac­tiv­i­ties, to ad­dress this un­ac­cept­able and pre­ventable cri­sis.”

The bill al­so pro­vides $7 mil­lion in sup­port of the Biden ad­min­is­tra­tion’s Can­cer Moon­shot pro­gram, ac­cord­ing to writ­ten tes­ti­mo­ny of chair of the sub­com­mit­tee San­ford Bish­op (D-GA).

Speak­ing at the sub­com­mit­tee hear­ing yes­ter­day, Rep. Andy Har­ris (R-MD) called the 10% in­crease in FDA’s bud­get “over­whelm­ing and un­nec­es­sary,” adding that, “rather than be­ing held ac­count­able, the FDA is be­ing re­ward­ed with more fund­ing.”

The full House ap­pro­pri­a­tions com­mit­tee plans to meet next Thurs­day to dis­cuss the FDA spend­ing bill, which al­so could reach a floor vote next month.

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

A manufacturing facility belonging to the Netherlands-based API producer Fagron Group has entered the FDA’s crosshairs after an employee destroyed a cleaning log, among other violations.

One of its plants in Saint Paul, MN received a warning letter on June 14, following an inspection last November that uncovered cross-contamination concerns.

“In your response, you provided a follow-up cleaning validation report in which you only assessed the carryover of niacin swab samples but not progesterone, which was included in your initial cleaning validation,” FDA says in the letter. “The lack of progesterone (b)(4) [commercially confidential information] is concerning considering the failing residue results you provided to investigators would yield unacceptable levels of progesterone cross-contamination.”

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.