K Street saw an­oth­er record year in 2021 for lob­by­ing ex­pen­di­tures, and some of the biggest bio­phar­ma com­pa­nies in the world shelled out mil­lions to sway Con­gress, re­veal­ing some of their key pri­or­i­ties along the way.

Pfiz­er topped the list of the largest phar­ma com­pa­nies in the lat­est quar­ter, spend­ing near­ly $3 mil­lion on lob­by­ing in Q4, which is about half a mil­lion more than they spent in the same quar­ter a year ear­li­er, but not quite as high as its Q1 2020 lev­el of more than $4 mil­lion. In 2021, Pfiz­er spent more than $10.3 mil­lion, about half a mil­lion less than in 2020.

Pfiz­er’s Covid-19 vac­cine com­peti­tor As­traZeneca and phar­ma heavy­weight No­var­tis spent about $1.5 mil­lion each in the lat­est quar­ter on lob­by­ing, which was al­so al­most dou­ble the amount each spent dur­ing the same pe­ri­od the pre­vi­ous year.

No­var­tis list­ed the pro­posed new NIH agency, to be known as the Ad­vanced Re­search Pro­jects Agency for Health (ARPA-H) as a fo­cal point, as well as biosim­i­lars, PDU­FA VII pri­or­i­ties and Cures 2.0.

Ab­b­Vie spent near­ly $1.3 mil­lion in the fourth quar­ter, end­ing the year spend­ing about $1 mil­lion more in 2021 com­pared to 2020. It list­ed sev­er­al in­di­vid­ual bills as “spe­cif­ic lob­by­ing is­sues,” in­clud­ing the Pre­serv­ing Ac­cess to Af­ford­able Gener­ics and Biosim­i­lars Act, which would lim­it “pay-for-de­lay” deals that pre­vent or de­lay gener­ics, and an­oth­er bill that went af­ter prod­uct hop­ping.

GSK al­so spent more than $1 mil­lion more on lob­by­ing in 2021 ver­sus 2020.

Nan­cy Pelosi

Along with the in­di­vid­ual com­pa­nies, in­dus­try groups PhRMA and BIO al­so lob­bied more heav­i­ly to cap­ture Capi­tol Hill at­ten­tion. PhRMA shelled out $7.2 mil­lion in the quar­ter, which was con­sid­er­ably more than the $5.1 mil­lion spent in Q4 2020, and BIO spent an­oth­er $3.4 mil­lion, which was on par with past months.

Joe Manchin

As ex­pect­ed, House Speak­er Nan­cy Pelosi’s HR 3 was fea­tured atop the list of lob­by­ing is­sues cit­ed among the com­pa­nies, as the bill would have in­tro­duced price ne­go­ti­a­tions in ways that could have cost in­dus­try hun­dreds of bil­lions of dol­lars over sev­er­al decades. The more wa­tered-down ver­sion of those ne­go­ti­a­tions, which was in­clud­ed in the re­cent­ly nixed (by Sen. Joe Manchin of West Vir­ginia, who has said he does back ne­go­ti­a­tions) Build Back Bet­ter Act, which was al­so list­ed as a pri­or­i­ty by just about every com­pa­ny.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

The Joint United Nations Programme on HIV and AIDS set a lofty goal back in 2019 to end the HIV epidemic by 2030. But according to the World Health Organization, infection rates are not falling rapidly enough to meet that target.

GSK’s ViiV Healthcare thinks it can help change that.

On Friday, ViiV announced that it’s in talks with the UN-backed Medicines Patent Pool (MPP) for patent rights to its cabotegravir long-acting HIV injectable for pre-exposure prophylaxis (PrEP) in low- and middle-income countries.