Policy Proposals

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On this page, you’ll find our analysis on key state and federal pharmaceutical policy proposals, with a focus on providing the expected economic impact from these proposals.

August 26, 2019 Policy Proposals, Price and Costs

Making medicines more affordable for patients promises to be a top policy priority for Congress when it returns from its August recess. Achieving this goal does not require new, elaborate, government programs or regulations. It requires reforms that will empower biosimilars to more effectively compete against originator biologics. To see why a little background is needed. Consider that the growth in spending on drugs that includes all discounts and rebates grew 3.5% annually between 2009 and 2018 according to IQVIA’s annual review of...

August 21, 2019 Blog, Policy Proposals

Politicians talk a lot about farming but seldom about “pharming,” even though the latter can also have a big impact on Americans’ pocketbooks—and their health. The punny name refers to genetically modifying plants such as corn, rice, tobacco and alfalfa to produce high concentrations of pharmaceutical ingredients. Many common medicines already come from plants, including morphine, the fiber supplement Metamucil and the cancer drug Taxol. Yet heavy-handed federal regulations have frozen out pharming efforts, making it far too difficult for...

August 5, 2019 Policy Proposals, Price and Costs

A smarter way to curb drug prices through imports By Henry I. Miller, M.S., M.D. and John J. Cohrssen The Trump administration last week announced steps that could lead to the importation of prescription drugs from Canada, where prices are lower. It is a goal supported by President Trump, but long opposed by many Republicans . . . Instead of pushing for piecemeal steps that will continually run into political opposition and legal challenges, the administration should take a broader approach — by establishing...

July 26, 2019 Policy Proposals

Opioids: Bad Science, Bad Policy, Bad Outcomes By Henry I. Miller, M.S., M.D. and Josh Bloom There’s an old joke about the drunk who’s hunting for his lost keys under the lamppost, not because he thinks they’re there, but because the light is good. Well, that’s what the feds and state governments are doing to try to quell the epidemic of opioid addiction and overdoses. The problem is quite real, but legislators and regulators are making incorrect assumptions and adopting flawed strategies. And...

July 19, 2019 Policy Proposals, Price and Costs

Report: Growing biosimilar market could save billions in health spending by Paige Minemyer Growing the biosimilar market could lead to significant healthcare cost savings, according to a new report, with the opportunity for billions in cost reductions. An analysis (PDF) from the Pacific Research Institute, a free market think tank, shows today the limited biosimilar market share saved about $253.8 million per year in spending. If biosimilars gained a 25% market share, those savings would increase to $2.5 billion, they said. If the market share increased further,...

July 18, 2019 Policy Proposals, Price and Costs

Cures for Cancer Could Grow on Trees By Kathleen L. Hefferon and Henry I. Miller Politicians talk a lot about farming but seldom about “pharming,” even though the latter can also have a big impact on Americans’ pocketbooks—and their health. The punny name refers to genetically modifying plants such as corn, rice, tobacco and alfalfa to produce high concentrations of pharmaceutical ingredients. Many common medicines already come from plants, including morphine, the fiber supplement Metamucil and the cancer drug Taxol. Yet heavy-handed...

July 12, 2019 Policy Proposals, Price and Costs

Biosimilars Struggle to Gain Market Share in the U.S., Analysis Shows By Alex Keown Over the past several years, the U.S. Food and Drug Administration has approved a number of biosimilar medications, therapies that have similar properties to a branded drug, but are different in composition, which differentiates them from generic drugs. The approval of biosimilar treatments has been supported at the highest levels as a means to increase competition in the market and help regulate some of the high costs of prescription...

July 12, 2019 Policy Proposals

This week, the Trump administration axed a proposal that would have saved American patients billions of dollars by shedding light on the complex drug supply chain. If enacted, the rule would have required insurers to share discounts they negotiate with drug companies directly with patients. The proposed rule would have changed the terms of Medicare Part D, which provides prescription drug coverage to more than 40 million elderly and disabled Americans. Part D plans are administered by private insurers who receive government subsidies. These insurers...

July 9, 2019 Policy Proposals

President Trump promised to reduce Americans’ pharmacy bills — and he’s delivering. His administration will soon finalize a rule that restructures the drug supply chain and ensure that tens of billions of dollars of hidden rebates and discounts flow to patients. The rule affects Medicare Part D, the federal prescription drug benefit for 45 million seniors and people with disabilities. Part D isn’t like other entitlement programs. Numerous private insurers compete to sell prescription drug plans to Medicare beneficiaries. The government...

July 9, 2019 Blog, Policy Proposals

The Trump Administration is proposing a litany of contradictory healthcare reforms. Some reforms will empower patients, improve incentives, and strengthen the healthcare system. Others empower bureaucrats, worsen incentives, and will restrict patients’ access to needed healthcare treatments. A better outcome will only emerge if the Administration jettisons the ill-advised proposals and focuses policy on eliminating the disincentives that pervade the current healthcare system. Starting with the bad, the Trump Administration is threatening to impose government-mandated price controls on pharmaceuticals. Of course, this...

June 11, 2019 Policy Proposals, Price and Costs

The Trump administration is planning to propose one of the biggest changes to Medicare in decades. The draft rule aims to reduce government spending by linking Medicare drug reimbursement rates to the rates in more than a dozen other Western countries that use price controls to hold down pharmaceutical spending. If implemented, the rule would effectively bring socialist drug price controls to the United States. Though the government would save some money in the short term, the change would threaten patients’ health and...

May 30, 2019 Innovation, Policy Proposals

The U.S. economy thrives on innovation. According to the U.S. Patent and Trademark Office, industries that intensively rely on intellectual property (IP) protections, which includes the biopharmaceutical industry, account for nearly 40 percent of the U.S. economy and are responsible for an outsized share of our overall economic growth. Beyond the growth benefits, innovations improve our lives in countless ways. From mobile technologies inaptly called “mobile phones” to cutting-edge medicines that treat formerly incurable diseases, innovation helps us live better lives. Within this...

May 20, 2019 Policy Proposals

Measles is making a comeback. As of May 17, there were over 800 reported cases of the disease, according to the Centers for Disease Control and Prevention. That’s more than in any of the last four years. This uptick is dispiriting but shouldn’t be surprising. More and more people are deciding not to get their shots. In the past decade, the number of nonmedical vaccine exemptions for philosophical reasons has increased in 12 of the 18 states that allow them. A surge...

May 16, 2019 Policy Proposals

There is a legal adage that “hard cases make bad law.” California may soon rediscover this wisdom. Assembly member Jim Wood has introduced a bill (AB 824) with the intention of discouraging “pay-for-delay” tactics. “Pay-for-delay” practices refer to a situation when a manufacturer of a patented drug pays the manufacturer of a generic drug to delay launching its competitive product in order to extend its exclusivity period. Undoubtedly, these practices are anti-competitive and violate the spirit of the entire patent system. Such...

April 1, 2019 Policy Proposals, Price and Costs

Senator Rick Scott (R-FL) has just doubled down on one of the Trump Administration’s unsound ideas. His proposal is disappointing for many reasons, particularly because Alex Azar, Secretary of Health and Human Services, has proposed an alternative reform that, if Congress implemented, would meaningfully improve the affordability of prescription drugs for patients. As part of the “Transparent Drug Pricing Act of 2019”, Senator Scott proposes to set the list price of all medicines to the lowest retail list price among five...

January 3, 2019 Policy Proposals

Too often, drug pricing analyses do not shed light on how much drug expenditures are actually increasing because these studies examine the wrong price. The latest iteration is an analysis by Rx Savings Solutions. According to the Wall Street Journal, Rx Savings Solutions documented that dozens of drug makers raised the list prices on hundreds of medicines for 2019. The average list price increase was 6.3%. Based on these findings, many people might reasonably conclude that patients will be paying more for...

October 29, 2018 Policy Proposals

Bringing a new drug to market now takes, on average, $2.6 billion and more than 10 years. Those numbers could shrink, and countless patients could benefit, if Food and Drug Administration regulators were less risk-averse. I know that from firsthand experience. Oct. 30 marks the 36th anniversary of the FDA's approval of human insulin synthesized in genetically engineered bacteria, the first product made with "gene splicing" techniques. As the head of the FDA's evaluation team, I had a front-row seat. Although...

October 24, 2018 Policy Proposals

Rarely is there bipartisan agreement that a tax cut won’t cost the federal government money. But, in the case of the medical device tax (a 2.3 percent tax on medical devices and products that was passed as part of the Affordable Care Act) this is true by definition because the tax is already suspended. The tax applies to medical devices such as pacemakers, advanced imaging technology (Cat Scan, MRI and ultrasound equipment), artificial joints, surgical gloves, and dental instruments. Devices that...

October 18, 2018 Policy Proposals, Studies

The controversial medical device tax hurts doctors, patients and manufacturers and should be repealed by Congress. The medical device tax imposes a 2.3 percent tax on such common items as pacemakers, CT scan machines, dental instruments, and artificial joints. It is currently suspended. Congress isn’t even collecting the revenue it anticipated, and it has also led to lower investment in research and development in new medical technology....