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A charity that helps patients pay for expensive prescription drugs is suing the federal government over what it alleges are unlawful federal restrictions that put a “stranglehold” on its ability to communicate with donors — which happen to be pharmaceutical companies that sell expensive drugs. Patient-assistance charities have become a mainstay of drug companies’ efforts to ensure patients can afford their products. It’s a circular kind of philanthropy: Drug companies give hundreds of millions of dollars a year to independent nonprofits, which in turn provide financial assistance for patients’ drug co-pays or other medical expenses. (Johnson, 1/8)

In arguing its case, Patient Services maintains an updated advisory opinion issued last March by the U.S. Department of Health and Human Services places “oppressive restrictions” on its ability to communicate with drug makers, hospitals, and other donors. Charities, which provide patients with financial assistance to obtain drugs, rely on these opinions to ensure they comply with the law. The modified opinion “ushers in a brave new world of government censorship and puts PSI in the impossible position of having to plan and set up new and modified disease funds without the benefit of the expertise of donors, prospective donors, or their purported affiliates who operate on the front lines in fighting these chronic diseases,” according to the lawsuit filed in federal court on Monday. (Silverman, 1/9)

Drugmakers can provide free medication to patients who can’t afford their prescriptions after a major industry-funded charity said it wouldn’t offer patients assistance in 2018, the federal government said. The charity, Caring Voice Coalition, had received hundreds of millions of dollars from drug companies, but said last week it won’t offer patients financial assistance in 2018 after losing a crucial stamp of approval from the U.S. government. (Langreth, 1/8)

Humira is the best-selling prescription drug in the world. You may have seen the commercials. Because of Humira, a woman with rheumatoid arthritis can wash her puppy in the bathtub, another with colitis can stroll happily through a fair packed with food vendors, while a third suffering from psoriasis can go to the gym without hiding her neck. (Hakim, 1/6)

After months of debate, New Jersey has formally adopted a tough rule that caps what doctors can earn from drug makers at $10,000 a year, and also limits meals given prescribers to just $15. The rule, which goes into effect on Jan. 16, was crafted in response to the ongoing opioid crisis and, specifically, rising concerns that some drug makers may use various forms of payments to influence prescribing of addictive prescription painkillers. (Silverman, 1/8)

Nevada officials have crafted a draft regulation that would allow companies to mark certain diabetes drugs pricing data as confidential when they begin complying with a new transparency law this coming spring. The move by the state Department of Health and Human Services appears designed to deflect a lawsuit filed recently by two pharmaceutical industry trade groups, that argued the law is unconstitutional and robs drug makers of their right to protect trade secrets. The law was adopted last summer and the draft regulations were released to provide guidance for companies, including pharmacy benefit managers. (Silverman, 1/9)

Eli Lilly & Co. Chief Executive Officer Dave Ricks said on Monday that the recent changes in U.S. tax policy will help the drugmaker lower its global tax burden as he continues to look for deals in areas like oncology. ... Lilly’s global tax rate will be lowered slightly as a result of the changes that President Donald Trump signed into law in December, Ricks said, adding that Lilly will be able to access cash regardless of where it’s stored. He said that foreign companies whose tax rates remain lower will affect dealmaking but Lilly will stand to be competitive. (Coons and Hopkins, 1/8)

The J.P. Morgan Healthcare Conference is just getting started, but one thing is already clear: Biopharma companies are positively giddy about the new tax law. The sweeping overhaul of the tax code, passed by the Republican Congress on Dec. 20, was a Christmas present with sweet implications for 2018, drug makers told investors at the industry’s annual confab here.Here’s a roundup of what some of the most closely watched companies had to say about the rewritten tax code. (Robbins, 1/8)

Last night, Celgene announced that it is buying Impact BioMedicines, a small biotech developing a drug to compete with the blockbuster blood cancer drug Jakafi, sold by Incyte and Novartis, in an announcement timed to coincide with the annual J.P. Morgan Health Care Conference, where Celgene, as it happens, always opens the show. (Herper, 1/8)

The government hasn’t even approved Alnylam Pharmaceuticals Inc.’s first drug, but officials at the Cambridge company are so optimistic the medicine will reach the market soon that they are planning a significant expansion. ... Patisiran would be Alnylam’s first approved drug since the company was founded 15 years ago. (Saltzman, 1/9)

Kmart has agreed to pay more than $1 million to settle allegations its pharmacies overbilled government health care programs for some prescription drug purchases in Illinois, the Illinois State Police said Tuesday. The deal is part of a $59 million settlement covering federal, state and insurance company claims against Kmart, part of Hoffman Estates-based Sears Holdings Corp., that the U.S. Department of Justice announced last month. (Zumbach, 1/2)