2020 candidates throw punches at drug industry Presented by the Partnership for America's Health Care Future

With help from Allie Bice, Arthur Allen and Rachel Roubein

On Tap

— Candidates continuing to lay into the pharmaceutical industry on the campaign trail.

— Senate Finance bill stalls over GOP resistance to Part D inflation caps.

— Patient group relaunching IPI campaign as other parts of Trump drug plan face setbacks.

A message from the Partnership for America's Health Care Future: Americans deserve choice and control, but the public option could eventually force all Americans into a one-size-fits-all government health insurance system. Learn more.

Happy Tuesday and welcome back to Prescription PULSE. I'm looking forward to reading Sarah Milov's The Cigarette: A Political History this fall, and hope she'll be on the airwaves soon to discuss! As always, send news and tips to Sarah Owermohle ([email protected] or @owermohle).

2020 Watch

2020 candidates throw punches at drug industry — Democratic candidates had strong words for pharmaceutical companies during a Monday AARP forum in Des Moines, Iowa, maintaining the tone set in the first round of primary debates last month.

“If Donald Trump doesn’t have the guts to stand up to the pharmaceutical companies, then elect me. I will.” That was New Jersey Sen. Cory Booker, who has been dogged in the past by criticism that he’s soft on the industry. Booker told the crowd that he drafted drug importation language with Sens. Bernie Sanders (I-Vt.) and Bob Casey (D-Pa.), and would “make sure we open up pathways” to import drugs if elected.

“There are two pharma lobbyists for every member of Congress. They think they own Washington — they don’t own me.” Minnesota Sen. Amy Klobuchar also talked up drug importation, noting she’d worked closely with Senate Finance Chair Chuck Grassley (R-Iowa) on a bipartisan bill. Both Klobuchar and Booker also talked about banning pay-for-delay agreements, with Klobuchar saying, “I have a feeling we can get this one done this year.” (Klobuchar’s pay-for-delay bill, S. 64 (116), hasn’t moved out of committee yet, but two House efforts, H.R. 1499 (116) and H.R. 2375 (116), have been approved by committees).

Former VP Joe Biden spoke hours after releasing a far-ranging health plan including drug pricing measures that mirror some of the efforts on the Hill and in the White House. The Democratic front-runner wants HHS to establish an independent review board that will link the price of new specialty medicines to the average price in other countries. He also wants to establish an inflation cap for Medicare and Medicaid programs that will carry over into the commercial sector.

But unlike the bill being negotiated in Senate Finance — and reportedly held up over GOP members’ Part D concerns (more below) — Biden wouldn’t make drugmakers pay a rebate if they hike prices over inflation. He would kick their products out of government programs entirely.

That should be incentive enough to keep costs low, he said: “If they’re that dumb that they’re going to give up their whole business, that’s fine.”

Also on his to do list: Biden said he would “double the amount of money that goes to NIH for research, particularly related to the brain,” and put $30 billion into creating a new research agency like the Defense Department’s DARPA, which has had a hand in medical research including vaccine studies.

Up next: Fifteen more presidential candidates will speak in Iowa cities over the next three days.

BIDEN CANCER INITIATIVE GOES ON HIATUS — The group said Monday it was suspending operations due to the "unique circumstances" of its namesake's status as front-runner for the Democratic presidential nomination. The decision scrambled plans for scores of projects the initiative has going in research, prevention, clinical trials, treatment access and data-sharing with everyone from the National Minority Quality Forum to Airbnb. The future of those projects is being negotiated, a spokesperson said.

... Biden, whose son Beau died of brain cancer in 2015, stumped for improved cancer treatment and research as part of the Obama administration's cancer moonshot, and created the initiative with his wife Jill two years ago. The two stepped down as chairs when Biden decided to run for president in April and that took the wind out of the initiative’s sails, a spokesperson said. "We remain personally committed to the cause, but at this time will have to pause efforts," said the group’s president, Greg Simon.

Critics had said any group with Biden's name attached would stand to receive favorable treatment from the government and other funders, but spokesperson Cecilia Arradaza said that criticism "did not play into the decision at all."

In Congress

SENATE FINANCE DRUG PACKAGE MIRED IN GOP CONCERNS — Committee Republicans are huddling Wednesday to discuss the drug pricing package being hammered out by Finance Chair Chuck Grassley and ranking member Ron Wyden (D-Ore.). Everyone is hoping for a CBO score by then on the measures aimed at slashing prices in Medicaid and Medicare Parts B and D. The score could chill or inflame skepticism boiling among Republicans on a Part D inflation cap in particular, wherein companies would pay a rebate back to the program if they hike prices over the inflation rate.

A similar plan in Part B seems to be doing fine, but Senate Republicans like Pat Toomey (R-Penn.) on Monday likened the Part D setup to price controls, Adam Cancryn reports. North Carolina Sen. Richard Burr said he’d have to see a CBO score before making any decision, but “I don't think we're anywhere close to moving forward.”

“I think there are lots of problems with the drug bill, lots,” Sen. Johnny Isakson said, naming “indexing” and inflation price caps as top concerns. A vote is unlikely before August recess, senators said.

Drug Pricing

P4AD RELAUNCHED CAMPAIGN BACKING THE INDEX PLAN — Patients for Affordable Drugs this morning relaunched a TV and digital ad campaign backing one of the White House's most ambitious proposed reforms “in light of recent setbacks for the administration blueprint.”

The nationwide ad campaign will tout the administration's proposal to link Medicare Part B payments to an index of lower international prices. A draft rule is currently sitting with the Office of Management and Budget, but President Trump recently suggested he could issue an executive order that sounded markedly similar. That so-called favored nations plan would pay for drugs based on the lowest price among a group of countries.

... Several of Trump’s other drug pricing plans fell apart last week as a judge struck down a requirement to put drug prices in TV ads and the president killed his own plan to eliminate rebates from the system amid concerns it would raise seniors’ premiums.

P4AD, a patient advocacy group backed by Arnold Ventures, says voters back the international price index by a 71-point margin. Watch the ad.

ICYMI: WHITE HOUSE TOUCHES ON IPI MODEL IN EXPERT MEETING — HHS Secretary Alex Azar and Domestic Policy Council chief Joe Grogan on Friday implored two dozen experts to rally their organizations behind the president's health agenda, Dan Diamond reported. While the threat of ‘Medicare for All’ was front of mind, sources say experts also grilled Azar on what some described as “socialist” policies like the international pricing index.

"We're not socialists," Azar said in response, according to two attendees.

SHORTENED EXCLUSIVITY COULD SAVE $31B — Brand-name medicines’ market exclusivity periods have climbed an average of 2.2 years since the mid-1990s, steadily delaying the market arrival of generic rivals. Reversing that trend alone could save the U.S. health care system roughly $31.7 billion, according to a Matrix report commissioned by the Coalition for Affordable Prescription Drugs, a group of insurers, pharmacy benefit managers and large employers.

Tactics ranging from patent thickets to citizens’ petitions and authorized generics — identical drugs produced or authorized by the brand-name company — have been some of the most effective ways to delay market competition, Matrix’s Alex Brill writes.

In the Courts

ARGUMENTS CONCLUDE IN NATION’S FIRST OPIOID TRIAL — The first trial of a drugmaker accused of fueling the opioid crisis is in the hands of an Oklahoma judge after the state and Johnson & Johnson gave closing arguments Monday, Paul Demko reports. The case is likely to have implications for hundreds of other lawsuits filed by cities, counties, tribes and hospitals.

Oklahoma Attorney General Mike Hunter depicted Johnson & Johnson as the “kingpin” of the state’s opioid crisis, while J&J’s lawyers countered that it was disingenuous to blame a single company for a complex public health issue. The case could be an unusual bellwether, Paul writes, because other drugmakers that have arguably been more significant players in the crisis — like Oxycontin maker Purdue Pharma — weren’t on the stand. Purdue reached a $270 million settlement with Oklahoma in March.

Eye on FDA

CBD COMMENTS CLOSE TODAY — FDA Principal Deputy Commissioner Amy Abernethy last week reminded everyone to submit comments on regulating CBD and other cannabis-derived products by July 16 — and said the agency is aiming to share its progress by the end of summer or early fall.

Some of the biggest questions on the FDA’s plate after a day-long public meeting on May 31 are establishing a line that would separate CBD-containing pharmaceuticals from retail products,tracking long-term safety and laying out ground rules for marketing and claims. “We are enthusiastic about research into the therapeutic benefits of CBD products but also need to balance safety,” Abernethy tweeted. State and federal lawmakers have urged the agency to clarify CBD’s stance.

… And ICYMI: e-cigarettes have a new regulatory deadline. A Maryland judge on Friday ordered e-cigarette manufacturers to submit applications for review by May 2020. The plan moves the deadline up by more than a year but grants FDA the extra months it said it needed to finalize guidance.

Coming Up in Pharma

Today: The House Energy and Commerce oversight subcommittee holds a hearing on federal efforts to fight the spread of fentanyl.

Quick Hits

PrEP COVERED BY INSURANCE, BUT OTHER BARRIERS REMAIN — Insurers will be required to cover PrEP with no out-of-pocket costs under a U.S. Preventive Services Task Force recommendation. But that doesn’t apply to the lab tests and other care that go with use of the preventive HIV medicine, Kaiser Health News reports. Truvada, the only drug approved to prevent HIV, is generally covered in state Medicaid programs. But KHN’s Michelle Andrews notes that in the south, where many states have not expanded Medicaid under the Affordable Care Act and HIV infection rates are high, barriers to access may even be getting worse.

DRUG-RESISTANT UTI ON THE RISE — Drug-resistant urinary tract infections are becoming more and more common, the New York Times reports. Data from the city’s Department of Health shows a third of UTIs caused by E. coli bacteria were resistant to Bactrim, a widely used drug for the infection, and many strains are resistant to ampicillin, once a gold standard of treatment. The Department of Health recently released an application for doctors and nurses to check different strains and their antibiotic resistance.

A message from the Partnership for America's Health Care Future: The public option is a one-size-fits-all new government health insurance system that could leave Americans with fewer choices at a time when millions are relying on access to high-quality care. A recent report found more than seven million Americans with private coverage could no longer have coverage through the marketplaces — with two million of those enrollees being forced off their private plans — after the first 10 years of the public option. Rather than leaving Americans with only one option, let’s build on what’s working where private coverage, Medicare, and Medicaid work together, not start over. Learn more.

Document Drawer

The World Health Organization and UNICEF recently released data that revealed 20 million eligible children were not given measles, diphtheria and tetanus vaccines in 2018.

A study published in Oxford Academic found that tobacco usage fell more in states that expanded Medicaid than in states that did not.

The Pacific Research Institute’s Center for Medical Economics and Innovation published an issue brief stating that the U.S. health system could save billions by expanding the use of biosimilars.

What We're Reading

‘COULD A LIVING SUBSTANCE BE A DRUG?’ — In The New Yorker, Siddhartha Mukherjee explores the question of how new “living drugs” are forcing the medical and pharmaceutical industries to face an important affordability question. He recounts how researchers discovered they could help cure cancers using patient’s own cells, but notes the industry doesn’t “entirely know how to regulate, or even conceptualize of, this new generation of drugs” — or how to price them. Novartis is selling one such therapy for $475,000. But Mukherjee notes that the estimated price tag to manifacture a CAR-T infusion is quite expensive: nearly six figures.

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