Believe it or not, there’s a way to lower prescription drug prices that has support from Democrats, Republicans, conservatives, liberals and many in the health-care industry. But it missed the boat on last week’s big spending bill, and doesn’t appear to have a spot in President Trump’s budget request this week, either.
There’s unusually broad support for the CREATES Act, which tries to even the playing field for generic drug developers who often run up against blockades from branded pharmaceutical companies seeking to keep their competition at bay.
Conservative firebrands such as Sens. Ted Cruz of Texas and Mike Lee of Utah and liberal diehards such as Sens. Dianne Feinstein of California and Sheldon Whitehouse of Rhode Island are co-sponsors of the bill. Groups ranging from Heritage Action and FreedomWorks on the right to Families USA and Public Citizen on the left are on board. So are the influential industry groups American Hospital Association and America’s Health Insurance Plans.
Yet the measure — notably opposed by the major drug lobby Pharmaceutical Researchers and Manufacturers of America — never made it into the final version of a sweeping bill to keep the government open that Congress passed last week, despite lots of chatter about it on Capitol Hill.
“I am also disappointed the agreement does not include the CREATES Act,” the bill’s sponsor, Sen. Patrick Leahy (D-Vt.), said in a floor speech Friday. “We can all agree that high drug prices are a problem as President Trump noted in his State of the Union address, and the CREATES Act offers a common-sense, bipartisan way forward.”
Nor does it appear to be among a slate of drug price-lowering proposals set to be included in the budget the White House is rolling out today, even though some of the ideas on the list would also require action by Congress. That list, which officials circulated last week, includes some Medicare and Medicaid changes to tweak prices downward, including cracking down on misclassification of drugs and allowing Medicare Part D drugs to provide zero-cost generics.
The problem CREATES tries to solve is this: It’s common for pharmaceutical companies to try to block competitors from creating generic versions of their products by either refusing to sell them the large quantities needed for the development process or by abusing special safety protocols as a way of safeguarding their drugs from competition.
Martin Shkreli, the infamous former CEO of Turing Pharmaceuticals, used this tactic to ward off competition to Daraprim, the company’s pill to treat serious parasite infections. Five generic companies sued Jazz Pharmaceuticals for similar actions on its sleeping drug Xyrem. In 2014, Mylan filed an antitrust lawsuit against Celgene, accusing it of blocking generic competition from the cancer drugs Thalomid and Revlimid.
CREATES tries to get at the issue by allowing generic companies to sue branded companies for failing to provide them with samples needed for testing. It also gives the Food and Drug Administration more leeway in approving alternative safety protocols if the branded company refuses to allow generic competitors to participate in a medication’s safety protocol.
The noticeably wide range of support for the bill is unusual, especially given that it hits at high prices — an issue whose range of possible solutions is deeply controversial on Capitol Hill.
“This is really about fundamental fairness,” Michael Brzica, vice president for federal affairs at the Association for Accessible Medicines, the trade association that represents generic drugmakers, told me last week. “Companies using this to protect themselves from would-be competitors I think strikes people on the right and the left as wrong.”
It’s a policy shift that FDA Commissioner Scott Gottlieb recently told me is one of the best ways to speed up the entry of cheaper generics into the marketplace and lower the price of drugs overall. Gottlieb called this practice of refusing to sell drugs to generic competitors a “pernicious” practice by pharmaceutical companies that breaks down the whole system.
“We have a system of market-based pricing, which is predicated on the notion there is going to be vigorous competition, but before that competition can occur, the generic company has to satisfy certain requirements and they can’t even get access to the doses they need,” Gottlieb told The Health 202 in December.
Leahy's office said the Congressional Budget Office has provided it with an analysis showing that the CREATES Act would reduce federal spending by about $3.8 billion over a decade by saving on drug costs for the Medicare and Medicaid programs. That means Congress could have an incentive to pass the measure as a way to pay for other priorities.
So why hasn’t Congress taken up the legislation yet? One force against it is the name-brand drug industry. But PhRMA Director of Public Affairs Andrew Powaleny contended the legislation wouldn’t affect many medicines — fewer than 45, he says — because CREATES would only apply to the small number of drugs that fall under the FDA safety protocol called Risk Evaluation and Mitigation Strategy (REMS).
“The current version of the CREATES Act would be a giveaway to trial lawyers by adding a new private right of action that would increase lawsuits and drive up costs for patients and taxpayers,” Powaleny contended.
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AHH: Consumer tools to help patients manage their health-care information are proliferating. But that has left the health-care landscape littered with digital walled gardens — web portals where patients can access their medical records, insurance company websites with information about their plan, and fitness apps where patients collect their own data, The Post's Carolyn Y. Johnson writes in a fascinating look at the tech industry's challenges in making the massively inefficient American health care system user-friendly.
"The $3.3 trillion American health-care system is seen by most everyone as ripe for disruption. Its inefficiency and complexity are apparent to providers and patients alike — and consumer technology giants, such as Amazon and Apple, have made it clear they’re interested in shaking things up," Carolyn writes.
"But the tech companies that have excelled at disrupting industries, from bookstores to taxis, have typically done it by improving and transforming the consumer experience. Efforts to upend health care in the same way face a major challenge: Most consumers engage with the system infrequently and, when they do, patient choice tends to be superseded by health insurance plans and doctors," she continues. "A person might find a doctor on one website but have to log in somewhere else to find out whether the physician is covered by their plan. People who search for their symptoms don't automatically get served information linked to their benefits, advising them on where they could go and how much it would cost."
OOF: The Drug Enforcement Administration is weighing whether to add kratom, an herbal supplement used as a pain remedy, to the same category of illegal drugs as heroin. The compound is gaining popularity as it’s thought to be safer than traditional opioid medications, such as oxycodone. But it’s also criticized as a dangerous and unregulated drug, and authorities warn it can lead to opioid-like abuse and death, our colleagues Katie Zezima and Laurie McGinley report.
The DEA has tried once before to curb access to kratom, but this time the FDA is supporting the crackdown, Katie and Laurie report. The FDA warns it has found the supplement contains opioid compounds with deadly side effects including seizures and depressed breathing, and notes there is no evidence it can be safely used medically, including to treat opioid withdrawal symptoms.
“Claiming that kratom is benign because it’s ‘just a plant’ is shortsighted and dangerous,” FDA Commissioner Scott Gottlieb said in statement. 'After all, heroin is an illegal, dangerous, and highly addictive substance' [derived from opium poppies]."
OUCH: There are more flu patients seeking care at doctors' offices and emergency rooms than at any time since the peak of the 2009 swine flu pandemic, The Washington Post's Lena H. Sun reports. Acting CDC director Anne Schuchat said although the numbers haven't reached pandemic level, they do signal "how very intense the flu season has been." "We may be on track to break some recent records," Schuchat told reporters on Friday.
"Pandemics occur when there is a new strain of virus for which people have no previous exposure. That's not the case here, because the seasonal strains that are circulating this year are not new," Lena writes. "But the predominant one, H3N2, is a particularly nasty strain that is associated with more complications, hospitalizations and deaths, especially among children, those older than 65 and people with certain chronic conditions."
Another 10 children died in the week ending on Feb. 2, bringing the total number of child deaths this flu season to at least 63. Data show flu activity is still widespread across the country, with overall hospitalizations higher than what officials normally see this time of year, especially among 50-to-64-year-olds, Lena writes.
--President Trump's' nonbinding budget proposal, scheduled to be released this morning, is more a reflection of his priorities than anything else. The White House has indicated it will include several policy proposals to lower drug prices, and it released a 30-page white paper Friday morning that promotes easing government regulations and spurring innovation aimed at lowering drug prices, while rejecting the idea of government price setting.
The document, written by the White House’s Council of Economic Advisers, blames the country's massive drug spending on nations that have fixed drug prices and a “free ride” off the innovation of companies that pay for drug research-and-development by raising their U.S. prices. It also proposes several changes to how Medicare and Medicaid pay for drugs and how the FDA approves and regulates them.
The paper lays out two overall goals to lower drug costs — reducing the price for biopharmaceutical products and expanding incentives for drug companies’ innovation — but soundly rejects the idea of the government negotiating down prices, as many Democrats and Trump himself have suggested for Medicare.
“Reducing drug prices that Americans pay means recognizing that many artificially high prices result from government policies that prevent, rather than foster, healthy price competition,” the report says. “Drug prices, for example, are sometimes artificially high due to government regulations that raise prices."
--The budget will also propose billions more in funding to fight opioid abuse, Bloomberg reports. But the agreement Congress passed just last week puts $6 billion over two years toward the epidemic, which White House counselor Kellyanne Conway touted on CNN yesterday. "That is more than we've ever seen for any administration," Conway said on "State of the Union."
Conway, who Trump has delegated to lead the administration's response to opioid abuse, said the $6 billion will go toward treatment for those struggling with addiction, law enforcement and public education. "We need to tackle all three at one," she said.
— Apparently the pharmaceutical industry is “livid” after lawmakers added into their big budget deal a provision closing the Medicare Part D “donut hole” a year earlier and forcing drugmakers to shoulder the burden, Axios reports. “They were completely blindsided,” an industry lobbyist told Caitlin Owens and Bob Herman.
The long-criticized “donut hole” gap in drug coverage — which leaves seniors paying a much larger share once the cost of their medicines hit a certain threshold — was supposed to be closed in 2020 under the Affordable Care Act. But the budget deal ends the gap in 2019 by making drug companies responsible for 70 percent of the costs instead of 50 percent, a move the companies say will cost them billions of dollars.
“Rather than prioritizing lowering seniors’ out-of-pocket costs, this proposal provides a massive bailout for insurance companies and undermines their incentive to reduce Part D costs, an incentive that has worked well for more than a decade,” Steve Ubl, CEO of the Pharmaceutical Research and Manufacturers of America, said in a statement.
--A few more good reads from The Post and beyond:
- The Senate Health, Education, Labor and Pensions Committee holds a hearing on reauthorization of FDA animal drug user fees on Tuesday.
- Kaiser Health News holds a discussion on living well with dementia on Tuesday.
- The Hill, Faces & Voices of Recovery and Indivior hold an event on the opioid crisis and supporting recovery on Wednesday.
- The Substance Abuse and Mental Health Services Administration holds a meeting of the Advisory Committee for Women's Services on women experiencing homelessness with behavioral health needs on Wednesday.
- The USC-Brookings Schaeffer Initiative for Health Policy holds an event on patient cost sharing for prescription drugs on Friday.
- The American Enterprise Institute holds an event on reforming foster care systems at the state level on Feb. 26.
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