Presented by the Partnership for America's Health Care Future
With help from David Lim, Sarah Karlin-Smith, Sarah Owermohle, Alice Miranda Ollstein, and Brianna Ehley.
— Coronovirus cases and deaths double as CDC urges travel restriction.
— Will Nancy and Donald resume bargaining on drug prices?
— Energy and Commerce considers bills on orphan drugs and generics.
Happy Tuesday and welcome back to Prescription Pulse! Guest editor Arthur Allen (@arthurallen202) is sitting in today for the coronavirus-afflicted (i.e., busy reporting about it) Sarah Karlin-Smith ([email protected] or @sarahkarlin) and Sarah Owermohle ([email protected] or @owermohle). As always, send hot tips and cunning perception to the Sarahs.
CORONAVIRUS UPDATE — CDC officials on Monday said roughly 110 people across 26 U.S. states were being investigated as possible cases of Wuhan virus infection. All five confirmed U.S. cases, and the suspected ones, involve people who traveled from China. On Monday afternoon, the agency advised against all non-essential travel to China.
… By late Monday, health authorities were reporting about 4,500 cases worldwide — the vast majority in China — and more than 100 deaths.
... The New England Journal of Medicine, which usually demands full exclusivity for data that appears in articles it publishes, broke with that tradition Monday, requiring authors of articles on the coronavirus outbreak to share important information with public health authorities as early as possible. The journal says it will share manuscripts with the World Health Organization and urges authors to submit their data on preprint servers like BioRxiv. If for space reasons it can’t publish a submission, it will allow authors to rapidly transfer their manuscripts to other journals.
ARE DRUG PRICING TALKS BACK ON? With President Donald Trump reportedly irked by his low ratings among voters on health care, House Speaker Nancy Pelosi is looking to revive drug price talks with his administration, six people familiar with the matter tell POLITICO’s Sarah Karlin-Smith and Adam Cancryn.
Pelosi’s top health aide, Wendell Primus, has floated the idea of reopening the discussions after Trump’s impeachment trial, the sources said. Primus’ aim is a May health care package that would also include measures to eliminate “surprise” medical bills.
But any renewed effort would face long odds in the election season. To get a deal Democrats would almost certainly need to back off on a centerpiece of the party’s drug pricing platform — that the government be authorized to negotiate drug prices — which would prompt outrage from the progressive flank.
Meetings between Pelosi’s office and White House aides over several months last year yielded little progress, prompting House Democrats in December to pass their own bill, H.R. 3 (116). Senate Majority Leader Mitch McConnell has shown little enthusiasm for advancing any health care legislation ahead of the election.
NOT ALL ORPHANS DESERVE OUR SYMPATHY — A bill that would make it harder for drugmakers to get orphan drug status for their products is among the bipartisan measures under discussion at a full House Energy and Commerce hearing Wednesday.
The Fairness in Orphan Drug Exclusivity Act, H.R. 4712 (116), would require companies to file annual disclosures showing they’re unable to recover the costs of developing and selling a drug without the seven-year exclusivity period granted for the treatment. It also would require FDA and the drugmaker to look into whether the manufacturer is selling other drugs for the disease or drugs of similar molecular composition.
… Accusations that drugmakers are abusing the 1983 Orphan Drug Act focused recently on Indivior’s buprenorphine formulations, used to treat opioid disorders. The FDA in November declined to allow orphan drug exclusivity for Indivior’s Sublocade in response to a petition filed by Braeburn, which otherwise wouldn’t have been able to sell its competing product until 2024. Drugs usually must serve fewer than 200,000 patients to get orphan status, but Indivior benefited from a loophole for firms expected to lose money by marketing a drug; instead it earned billions because of the opioid crisis.
… The committee will also discuss the MODERN Labeling Act, H.R. 5668 (116) from Reps. Doris Matsui and Brett Guthrie, which would allow FDA to order generic drug labels to be updated with any safety problems or new indications. Generics are required to have the same labeling as the brand drug they reference, but aren’t allowed to independently update labeling if sales of the brand product lapse. A 2017 California Supreme Court ruling held that brand-name companies could be held liable for injuries caused by generic versions even if they no longer made the original drug.
… The House will also consider two items authored by Guthrie and Energy and Commerce Chairman Frank Pallone: one to finance national centers for excellence in continuous pharmaceutical manufacturing, aimed at improving drug quality and reducing shortages, and another to authorize FDA to destroy misbranded or faulty imported medical devices.
HOUSE DEMOCRATIC GROUP LAUNCHES DRUG PRICING AD BLITZ — The DCCC announced Monday that it’s dropping seven figures on ads hitting Republicans for not taking action on drug pricing, POLITICO's Alice Miranda Ollstein reports. The ads will run on various platforms, in English and Spanish, including in battleground districts in Michigan, Pennsylvania, Nevada, Georgia and Florida.
… Pressure builds for GOP action: The DCCC’s announcement comes just a few weeks after President Donald Trump blew up at HHS Secretary Alex Azar over his administration’s lack of progress on lowering drug prices and polling showing voters prefer Democrats on health care. Some Senate Republicans working to protect their majority have fretted that inaction on drug prices could hurt vulnerable members.
This political pressure has revived talks on Capitol Hill over a bipartisan drug price bill, S. 2543 (116), but it has so far received scant Republican support, and Democrats are looking to capitalize on this stalemate.
IPI WATCH — The White House told drug industry representatives late last week to expect the release of a controversial proposed rule in the next two weeks tying the reimbursement rate for Medicare Part B drugs to the lower prices paid overseas, three sources told Sarah Karlin-Smith. The White House did not respond to a request for comment.
This follows Sarah and Adam Cancryn’s reporting last week that the administration is scrambling to finish the plan the administration first floated in 2018 in time for Trump’s State of the Union address Feb. 4.
Trump is angling for a win with the public. But the slow nature of federal rulemaking means this plan is unlikely to have any impact on consumers before the 2020 election.
BANNING FENTANYL?: The Justice Department is pressing the House to follow the Senate in extending an emergency order that banned all fentanyl-related products. The DEA-issued ban, which went into place in February 2018, has contributed to a 50 percent reduction in fentanyl and related drugs encountered in the U.S., Deputy Attorney General Jeffrey Rosen said in a news release. The ban, which does not affect already approved prescription versions of fentanyl or related drugs, expires Feb. 6 unless Congress extends it.
… Assistant Secretary of Health Brett Giroir and Amanda Liskamm, the senior Justice official for opioid enforcement, are among those testifying at a House Judiciary hearing this morning on the classwide ban. Fentanyl and analog drugs have become the deadliest component of the opioid epidemic, killing 28,400 people in 2017 alone, according to CDC data. A coalition of civil rights and harm reduction groups oppose the extension of the ban, saying it brings longer prison sentences that threaten to repeat the excesses of the war against crack cocaine.
“We’ve tried supply reduction decade over decades. We don’t want to throw it out entirely but it just doesn’t work as well as its sellers claim,” Dan Ciccarone, a University of California, San Francisco physician and harm reduction specialist, told POLITICO. Fentanyl deaths went up month by month through mid-2019 despite the ban, he noted, and some fentanyl analogs may have beneficial uses, so a blanket ban could be counterproductive.
LEGAL WOES FOR THE KING OF THE PHARMA BROS — New York Attorney General Tish James and the Federal Trade Commission filed suit against Vyera Pharmaceuticals and its former CEO, Martin Shkreli, on Monday, accusing it of illegally monopolizing a common drug used to treat life-threatening parasitic infections, reports POLITICO's Amanda Eisenberg.
The suit, filed in federal court in Manhattan, alleges that Vyera raised the price of Daraprim by more than 4,000 percent and then sought to prohibit its distribution to generic companies. It also allegedly cut off access to pyrimethamine, the drug’s active ingredient, according to the state AG’s office.
“We filed this lawsuit to stop Vyera’s egregious conduct, make the company pay for its illegal scheming, and block Martin Shkreli from ever working in the pharmaceutical industry again,” James said in a statement. The drugmaker, then known as Turing Pharmaceuticals, acquired the rights in 2015 to Daraprim, an important drug for some AIDS patients, then raised the price from $17.50 to $750 per tablet.
Vyera did not respond to a request for comment.
BLOOMBERG TAKES ON DRUG PATENTS — The former New York City mayor would give new drug and biologic applications just one 20-year patent, preventing manufacturers from delaying cheaper generic competition by amassing dozens, if not hundreds of patents to fend off copycat products. Drug companies that submit supplemental applications for a new indication for an approved drug also wouldn’t get any new marketing protection, the Bloomberg campaign told POLITICO.
Drug industry critics argue that brand companies sometimes make small tweaks to drugs that offer little if any clinical benefit to gain patents and keep extending their monopoly for years.
PhRMA spokesperson Tom Wilbur told POLITICO that new versions of approved medicines “expand treatment options and result in improved health outcomes for patients.” Wilbur said a medicine’s intellectual property may range from its active ingredients to manufacturing processes.
... PBMs also affected — Bloomberg’s drug pricing plan also borrows from an idea that Trump abandoned — a change to the drug rebate system. Bloomberg would revoke the safe harbor protection that allows drug companies to provide rebates and other payments to pharmacy benefit managers in exchange for better formulary placement. Instead, the Bloomberg campaign said drug manufacturers would need to compete on price and efficacy of their products.
Bloomberg's campaign has not said whether it would revive a part of Trump's plan that would allow drug rebates if they were directly passed on to consumers at the point of purchase.
SURGICAL GOWN RECALL TIMING RAISES QUESTIONS — Cardinal Health admitted it heard a Chinese contractor was making its surgical gowns at two unapproved sites a month before it told the FDA and issued alerts about contamination concerns that have since prompted a recall of more than 9 million of the products and a supply crunch at U.S. hospitals.
The company, one of the nation's biggest manufacturers of so-called Level 3 gowns used for joint replacements and other procedures, received a Dec. 10 phone tip that Siyang HolyMed was manufacturing products at plants not registered with the FDA, according to spokesperson Erica Lewis.
Cardinal quarantined the gowns while it investigated if they were mixed with others made at an FDA-registered site and subsequently decided to begin the process of voluntarily recalling 9.1 million of the garments on Jan. 9. The FDA was told the next day.
Asked if the company should have moved faster, Lewis said Cardinal "has been fully cooperating with FDA and has been open about what is known to date."
The recall has upended the hospital supply chain.
Nancy Foster, the American Hospital Association's vice president of quality and patient safety, said some of her trade group's members are weighing whether to cancel operations or other medical procedures this week while others are managing supplies "by being very judicious in how they use gowns and surgical kits.”
MEDICARE EXPANDS CANCER-RISK GENETIC TESTING — CMS on Monday expanded Medicare coverage of Next Generation Sequencing diagnostic tests to include certain patients with germline ovarian or breast cancer.
Under the new National Coverage Determination, which broadly tracks with its October 2019 draft, CMS also granted Medicare Administrative Contractors additional capacity to determine if germline NGS testing is appropriate for a broader swath of cancer patients at risk of hereditary cancers.
CMS issued a new coverage determination in March 2018 that raised concerns its policy would limit NGS testing coverage for early stage cancer patients.
The FDA Monday released draft guidance outlining recommendations, such as design considerations, for sponsors submitting 510(k) applications for multi-patient arthroscopy pump tubing sets. The agency said it has received reports of patient fluid traveling backward through irrigation tubing during arthroscopic procedures, which carries a risk of disease transmission between patients.
FDA on Friday issued guidance on regulatory considerations for use of minimal disease in developing treatments of blood malignancies.
FDA issued guidances for clinical drug interaction studies on Cytochrome P450 enzyme- and transporter-mediated drug interactions and in vitro drug interaction studies on Cytochrome P450 enzyme- and transporter-mediated drug interactions.