Frank Pal­lone, rank­ing mem­ber of the House En­er­gy & Com­merce Com­mit­tee, crit­i­cized the FDA and NIH to­day for not do­ing enough to pre­vent phar­ma com­pa­nies from fail­ing to re­port cer­tain clin­i­cal tri­al re­sults to the gov­ern­ment data­base, Clin­i­cal­Tri­als.gov.

Point­ing to a re­cent study, Pal­lone said that while com­pli­ance with Clin­i­cal­Tri­als.gov re­port­ing re­quire­ments “has slow­ly but steadi­ly im­proved since 2007, sig­nif­i­cant gaps re­main.”

In a 2021 study of all reg­is­tered tri­als com­plet­ed af­ter Jan­u­ary 2017, spon­sors of on­ly 40% of tri­als re­quired to re­port re­sults did so with­in one year of com­ple­tion, as re­quired by law, and un­der 69% did so at any time.

“FDA, which bears re­spon­si­bil­i­ty for en­forc­ing Clin­i­cal­Tri­als.gov re­quire­ments for a much larg­er num­ber of tri­als, has al­so tak­en very lim­it­ed ac­tion to en­sure com­pli­ance,” Pal­lone wrote. “This is con­cern­ing con­sid­er­ing that it is ap­par­ent when FDA takes ac­tion, it has great ef­fect. FDA first be­gan is­su­ing Pre-No­tice let­ters in 2013, six years af­ter FDAAA was en­act­ed.”

Pal­lone al­so ques­tioned FDA, giv­en the large num­ber of tri­als that ap­pear to be non­com­pli­ant and the suc­cess of FDA’s non­com­pli­ance let­ters so far, whether the agency plans to send these let­ters more fre­quent­ly in the fu­ture. And if not, why not?

The let­ter comes as most NIH-fund­ed clin­i­cal tri­als with re­sults due in 2019 and 2020 did not meet fed­er­al re­port­ing re­quire­ments, the HHS in­spec­tor gen­er­al’s of­fice said in an au­dit re­leased last Au­gust.

“NIH did not have ad­e­quate pro­ce­dures for en­sur­ing that re­spon­si­ble par­ties sub­mit­ted the re­sults of clin­i­cal tri­als, took lim­it­ed en­force­ment ac­tion when there was non­com­pli­ance, and con­tin­ued to fund new re­search of re­spon­si­ble par­ties that had not sub­mit­ted the re­sults of their com­plet­ed clin­i­cal tri­als,” HHS’ OIG re­port says.

Pal­lone lat­er ques­tioned if the process by which FDA re­views these non­com­pli­ant spon­sors should be dif­fer­ent, not­ing:

Is it nec­es­sary to con­duct an in­spec­tion or re­ceive a com­plaint to de­ter­mine whether a spon­sor or tri­al is sub­ject to and in com­pli­ance with Clin­i­cal­Tri­als.gov re­quire­ments, or is FDA able to more ef­fi­cient­ly de­ter­mine this through oth­er means, such as re­view of spon­sor sub­mis­sions or com­mu­ni­ca­tions with spon­sors.

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.