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February 7, 2019 Price and Costs

By Henry I. Miller, M.S., M.D. and Jeff Stier Trump administration officials keep searching for solutions to rising prescription drug prices, which are increasing faster than inflation. "Drug makers and companies are not living up to their commitments on pricing. Not being fair to the consumer, or to our Country!" President Trump tweeted on Jan. 5. Most of the administration's suggested remedies have been threats or the imposition of various types of price controls. On Thursday, Jan. 31, Department of Health and...

February 4, 2019 Innovation

By Mia Zaharna, MD and Henry I. Miller, M.S., M.D. Insomnia is a common and often frustrating sleep disorder that can make it hard to fall asleep, to stay asleep, or cause you to wake up too early and not be able to get back to sleep. It can adversely affect your health, work performance, and quality of life. It can also be hard to treat, even by experts — but help, in the form of technology, is on the way. Although...

February 4, 2019 Price and Costs

In mid-January, three Democrats — Vermont Sen. Bernie Sanders, Maryland Rep. Elijah Cummings, and California Rep. Ro Khanna — introduced legislation that aims to reduce prescription drug prices. Their plan would essentially peg U.S. drug prices to those in five foreign countries where prices are typically lower because their governments forcibly control them. It would also open our borders to imported drugs from Canada and other countries. Their proposal is painfully shortsighted. It would slow pharmaceutical innovation and expose patients to dangerous counterfeits in...

January 24, 2019 Price and Costs

President Donald Trump and Sen. Bernie Sanders don’t agree on much. But they both believe in price controls. Both men recently introduced separate proposals to impose price controls on prescription drugs. Though both men are likely well-intentioned, their plans are deeply misguided. Both proposals would discourage drug research and reduce access to medicines. The Trump administration’s proposed rule, released this fall by Health and Human Services Secretary Alex Azar, would change the way Medicare pays for most cancer drugs and other medicines...

January 17, 2019 Price and Costs

In one of his first acts, Governor Newsom signed an executive order that will change how medicines are purchased in California. With visions of big-box store discounts dancing in his head, Governor Newsom has established a bulk program that will now purchase drugs for the state’s Medicaid program (Medi-Cal). The Governor believes that his executive order will create significant health care savings for the state, but he will be sorely disappointed. Imposing more government mandates and increasing bureaucratic control of the...

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...

December 31, 2018 Price and Costs

On Dec. 18, Sen. Elizabeth Warren, D-Mass., introduced the Affordable Drug Manufacturing Act. The bill would create an Office of Drug Manufacturing to produce and sell generic medications. Warren hopes this government entity would solve "market failures" — her term for generic drug shortages and steep price hikes on off-patent medicines. The plan is absurd. The federal government has no business operating a drug manufacturer. If federal officials want to expand access to generic drugs (a worthy goal) they should harness the power of free markets. Within...

December 17, 2018 Innovation, Price and Costs

Despite the constant barrage of negative news, this is an exciting time for patients. Truly innovative medicines and gene therapies are under development. New gene therapies are particularly exciting because these therapies do not just treat diseases – they often cure them by fixing underlying genetic defects, frequently with only one dose. There is great optimism that these fundamentally new therapies will, ultimately, cure diseases like hemophilia and sickle cell disease, and even many ultra-rare diseases that were previously untreatable. Take...

December 12, 2018 Innovation

Government solutions often come with a price. For the America Invents Act (AIA), this price was an unintended impediment to medical innovation. Proposed legislation known as the Hatch-Waxman Integrity Act can reduce these costs, if Congress takes advantage of the opportunity. The problem of patent trolls plaguing Silicon Valley was a well-documented, and troubling, problem. Patent trolls are entities that obtain patents, often obscure patents, for the sole purpose of filing lawsuits in court. The troll then uses the threat of...

December 11, 2018 Innovation

Sen. Bernie Sanders, I-Vt., and Rep. Ro Khanna, D-Calif., recently proposed bills that would impose price controls on prescription drugs. The legislation would require pharmaceutical companies to sell their medicines in the United States for no more than the median price charged in five countries – Canada, the United Kingdom, France, Germany, and Japan. If companies refuse to cut prices in the United States, the federal government could revoke existing patents or market exclusivities and allow generic drug manufacturers to sell knockoff copies...

December 6, 2018 Innovation

Animal products used in or on humans have been an invaluable part of medical practice for almost a century. Examples include animal insulins to treat diabetes and pig heart valves transplanted into humans. A related medical breakthrough was just published on Dec. 5 in the journal "Nature": Genetically modified pig hearts transplanted into baboons can function long-term, a major step towards the clinical use of pig donor hearts in human patients. But suppose bioethicists objected, on the grounds that such mixing of...

November 19, 2018 Price and Costs

There is no shortage of bad ideas when it comes to the pharmaceutical market. One such proposal would allow drugs to be imported directly from other countries, such as Canada. Then there is the Trump Administration’s proposal that would effectively adopt foreign price controls on Medicare Part B drugs by implementing an international pricing index (IPI). These policies, if implemented, would harm the quality of health care in the U.S. by reducing patients’ access to medicines and harming future innovations. What’s...

November 16, 2018 Price and Costs

Health and Human Services Secretary Alex Azar just released a sweeping proposal that would drastically change how Medicare pays for advanced cancer therapies and other potent medicines. The plan relies on foreign price controls to reduce drug spending by $17 billion over five years. Although drug spending may decline, as the Congressional Budget Office has noted, the plan could result in increased healthcare spending elsewhere, as patients will inevitably lose access to medicines. So while the savings is questionable, the negative...

November 9, 2018 Price and Costs

Last month, the Trump administration proposed several reforms to drive down prescription drug prices. One measure would force pharmaceutical companies to mention the sticker prices of their medicines in television advertisements. The new mandate covers all prescriptions drugs reimbursed by Medicare or Medicaid that cost more than $35 a month. The administration hopes this change will empower patients to choose more affordable drugs and embarrass companies into reducing their prices. But the rule won’t achieve those goals. Instead, it would mislead customers into thinking drug prices are...

November 4, 2018 Innovation

Seasonal outbreaks of the flu cause thousands of deaths even in a good year, and the last flu season, 2017-2018, was a terrible one. It killed 80,000 Americans and sent 900,000 to the hospital, making it the worst influenza season in decades. Data from the Centers for Disease Control and Prevention (CDC), show how much of an outlier it was: Previously, seasonal outbreaks since 2010, had killed between 12,000 and 56,000 and caused between 140,000 and 710,000 hospitalizations. Statistics like that can seem impersonal,...

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 23, 2018 Price and Costs

This month, the Trump administration proposed a new rule that would require advertisements for prescription drugs covered by Medicare or Medicaid to include the list price of the medicine. To be sure, a free market is dependent on consumers making informed decisions. But this move would provide patients with incomplete, misleading numbers that would muddle their healthcare decisions. Patients almost never pay the full list price for their medication. After a drug is manufactured by a pharmaceutical company, its price and distribution are influenced by...

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....

October 17, 2018 Price and Costs

The largest problems in the health care industry are often created by reformers envisioning themselves as free market saviors, when in reality they are merely advocates for more intrusive government regulations. The Trump administration’s proposal to require that drug advertisements include the medicine’s list price is such an example. On its face, requiring price disclosure appears to promote transparency and free markets. Why shouldn’t consumers know the price of a good before they purchase it? Of course, consumers should. The problem is that,...