Archive

Posts Tagged ‘Pharmaceuticals’
November 19th, 2018 at 11:14 am
Quote of the Day: John Stossel On the Dangers of Government Drug Price Controls
Posted by Print

In our recent weekly Liberty Update commentary entitled “On Pharmaceuticals, HHS Contemplates Disastrous New Price Controls,” we explain how government price controls undermine intellectual property (IP) rights, stifle American innovation and ultimately punish consumers in the form of fewer new pharmaceuticals.  We therefore encourage the Trump Administration to rethink a toxic new proposal along those lines, and instead pursue a course more in accord with its generally excellent stewardship of our economy and markets to date.

In his latest weekly commentary entitled “Not Healthy to Be Naive,” John Stossel agrees, and in a nice blurb explains the real-world consequences of drug price controls:

[G]overnment-run systems save money by freeloading off American innovation.  American drug companies, funded by American customers, fund most of the world’s research and development of pharmaceuticals.  New drugs and devices are expensive, so sometimes in Britain, says Pope, ‘whenever a new drug comes on the market that can save lives, the government just doesn’t have the funds to pay for it.’

Patients, accustomed to accepting whatever government hands out, don’t even know about the advances available elsewhere.  Single-payer systems also save money by rationing care.  Hence the long waiting times for treatments declared ‘nonessential’ in Canada, Britain and, for that matter, at American veterans hospitals.”

Hopefully, the Trump Administration is listening and corrects course.

October 25th, 2018 at 2:09 pm
HHS Prepares to Commit Unforced Error On Drug Price Disclosure Mandate
Posted by Print

Healthcare costs, including pharmaceutical costs, remain a legitimate concern.  But the Trump Administration Department of Health and Human Services (HHS) is about to commit a needless unforced error.

The issue in question is an effort to force pharmaceutical companies to announce “list price” of drugs that they advertise.

A similar effort was recently introduced as legislation in Congress by Senator Dick Durbin (D – Illinois), which is itself proof of the wrongfulness of the idea.  A coalition of conservative and libertarian voices, including CFIF, stopped Senator Durbin’s effort.  But for some reason the HHS announced intent to impose the mandate via regulation, reminiscent of Barack Obama’s “pen and phone” manner of presiding.

Here’s why this is a terrible idea.

First, a drug’s “list price” is more likely to confuse consumers than enlighten them.  The reason is that what consumers actually pay for a drug is almost always very different, and much lower, than its list price.  Most patients’ drugs are subsidized by co-pays or co-insurance programs, whether via Medicare, Medicaid or insurance companies.  Insurance companies themselves typically don’t even pay the full list price, since they also receive various rebates and discounts from pharmaceutical sellers.  Overall, approximately 9 out of 10 consumers pay below the technical list price.  Consequently, compelling advertisers to state the list price in ads would mislead consumers into assuming that their out-of-pocket cost would be higher than they price they’d actually pay.

That hardly advances the goal of informing consumers.

An even more fundamental problem with the contemplated HHS mandate is that it would violate the First Amendment by compelling speech.

Under First Amendment free speech application, including commercial speech, courts strictly scrutinize any effort by government to force private citizens or entities to what it wants them to say.  Only where the compelled speech is purely factual and non-controversial will allow exceptions to the general prohibition against compulsory words.  As noted above, a drug’s list price doesn’t qualify as purely factual for purposes of informing consumers, because consumers rarely pay that price.  Nor does the HHS proposal qualify as non-controversial, for obvious reasons.

Accordingly, a government attempt to force advertisers to state prices that are higher than what almost all consumers actually pay can’t withstand First Amendment scrutiny, and will be struck down when challenged in court.

Finally, the HHS doesn’t even possess authority to impose this proposed mandate.  That authority under Congressional statute instead lies with the Food and Drug Administration (FDA).  Proponents of the HHS mandate assert that the Social Security Act provides a loophole to force this proposal upon the pharmaceutical market, but that too won’t withstand court scrutiny.

For all of these reasons, the HHS proposal to engage in compulsory speech, speech that isn’t even accurate or informative, is a head-scratcher.  Hopefully it will reconsider this ill-advised effort sooner rather than later, and pursue more effective ways of reducing pharmaceutical and healthcare costs.

July 13th, 2018 at 9:37 am
The Price and Importance of Innovation

America’s pharmaceutical innovators lead the world, saving and improving people’s lives on a daily basis.  But relentless efforts to move toward a single-payer system and impose destructive price controls threaten our continuing progress.

Drug maker Biogen recently announced exciting results of a clinical trial for a new drug to treat Alzheimer’s disease. Yet, despite the promise that this could be a breakthrough that gets us closer to a cure, the medical community and families with loved ones suffering from the disease are holding their collective breath.

Why? Because we’ve been down this road before.

Alzheimer’s is one of the most complex and pernicious medical conditions that we face, with no known cure and an immense emotional and economic toll. Worse, the rate of diagnosis is increasing and estimates suggest the cost of the disease has already surpassed $259 billion.  According to one Alzheimer’s Association spokesperson, it will “bankrupt Medicare.” By 2050, the cost of care for Alzheimer’s patients could exceed $1 trillion annually.

That is a crisis medical professionals are rushing to solve, but progress has been slow. An estimated 99.6 percent of Alzheimer’s drug “candidates” (i.e. experimental drugs designed to treat Alzheimer’s) fail.

In 2018 alone, high profile failures in Phase 3 clinical trials from drug makers like Eli Lilly and Merck represent decades of work and hundreds of millions of dollars in research yielding little to no results. Even Biogen’s announcement, as promising as it is, has only a 50 percent chance of gaining FDA approval, according to analysts.

The issue of high drug prices is real, but too often the public doesn’t understand the immense risk – and cost pharmaceutical companies take on to research and develop new treatments for devastating diseases like Alzheimer’s. While everyone hopes Biogen’s new drug is a success, many drugs – including many recent potential treatments for Alzheimer’s – never make it through the clinical trials to market. What’s worse, the lack of transparency in our health care payment system drives costs up even further.

Drug makers invest hundreds of millions of dollars and more into developing new treatments and cures, with no guarantees their research and development will yield results.  That risk must be protected to ensure the continued motivation to strive for better treatments and new cures.

Efforts to cap prices and leverage government buying power via a single-payer system threaten to curtail research and delay or eliminate future cures. It’s a gamble that the United States cannot make, both for our own health and for future generations.

May 10th, 2017 at 2:36 pm
Senate Confirms Trump Nominee and Drug Importation Skeptic Gottlieb as FDA Chief
Posted by Print

Yesterday brought good news in the form of Senate confirmation of Trump nominee Scott Gottlieb as Commissioner of the Food and Drug Administration.  In addition to favoring quicker pharmaceutical review and approval, as well as “free-market strategies to bring down drug costs,” The Wall Street Journal notes that Gottlieb brings a healthy skepticism of the ill-advised and potentially dangerous proposal to import drugs from Canada and other countries:

He has also questioned the wisdom of allowing U.S. consumers to import brand-name drugs from countries like Canada, where they cost less, in part because of safety concerns.”

Mr. Gottlieb’s view accords with the opinion of all four of the most recent FDC commissioners, who warned in a recent letter to Congress that suddenly allowing drug importation from Canada or other unsecure countries “is a risky approach that would endanger consumers by exposing them to fake, substandard and contaminated drugs”:

[G]lobal experience confirms that illicit, ineffective, or adulterated products are readily available on the open market and represent one of the most lucrative avenues of organized crime…  Obtaining sufficient resources and expertise to screen and verify the authenticity of every product destined for American consumers presents enormous challenges.”

That also accords with the view of former federal judge and Clinton and Bush FBI Director Louis Freeh, writing in The Philadelphia Inquirer:

Allowing citizens to purchase medicine direct from foreign countries will mean more risk to consumers from counterfeit drugs, more opportunity for criminal activity in the marketplace, and more stresses placed on overstressed law enforcement efforts to combat this problem.  The belief that U.S. consumers can gain access to safe and low-cost medicines from Canadian and European drug markets without an offsetting cost to consumer confidence and law enforcement is not realistic.  Quite the contrary, drug counterfeiting is a global threat that we’re inviting upon ourselves if Congress allows this idea to move forward.”

Drug importation is a deceptive and dangerous idea, particularly in a period of increasing opioid addiction across the country, and Congress shouldn’t make the country more perilous by pushing it.

July 18th, 2016 at 12:11 pm
Intellectual Property Protection Means Greater Biomedical Innovation
Posted by Print

Reasonable people understand that nations more protective of property rights and the rule of law enjoy higher levels of innovation and prosperity.  The fields of pharmaceutical advancement and biomedical innovation more specifically are no exception.

In a cogent new piece, U.S. Chamber of Commerce Executive Director of Intellectual Property Policy Patrick Kilbride demonstrates how strong intellectual property (IP) protections fuel biomedical innovation that benefits the world:

[E]conomies with the strongest IP protections are 60 percent more likely to provide environments conducive to biotech innovation.  And economies with specific protections for the life sciences field see an average of 13 times more biomedical investment than those lacking IP protections…  [A]s intellectual property systems have strengthened over time, public and private investment in health care has increased, as well as individual earnings to support heath costs.”  (emphasis in original)

Why does that matter?  Because international and even domestic forces seek to  undermine IP protections, threatening the goose that continues to lay golden eggs:

We live in a world where concerted efforts are being made daily to erode intellectual property rights, based on the false premise that IP somehow threatens access to medical care.  While the facts simply don’t support this theory, it hasn’t stopped activists around the world from spreading misinformation and chipping away at the very IP protections that produced life-saving medicines in the first place.  Just a few short years ago, India stripped a leukemia drug of its patent, claiming that it inhibited access by its citizens.  The result?  Due to government interference, fewer Indian citizens had affordable access to this medication than before the patent was annulled.  In Canada, an overzealous judiciary revoked 25 previously granted pharmaceutical patents and sparked a case involving NAFTA protections that could do lasting harm to future investments in life-saving medicines.  And Colombia’s prime minister of health has repaid medical researchers scrambling to find a cure for the Zika epidemic by pursuing an arbitrary and dangerous attack on others in the industry, effectively stripping a pharmaceutical company of its patent for another drug.  It is also against this backdrop that the United Nations Secretary General has pressed for establishment of a High-Level Panel on Access to Medicines (HLP) to quickly produce a report, based on the same false premise:  that ‘failure to reduce the costs of patented medicines is resulting in millions of people being denied access to lifesaving treatments.'”

As Abraham Lincoln observed, “The patent system added the fuel of interest to the fire of genius.”  It’s incumbent upon us to safeguard IP protections that continue to fire the genius of medical innovation.  Too many lives are at stake across the world to allow the grim alternative.

December 21st, 2015 at 9:48 am
Before You Complain About Drug Costs…
Posted by Print

Maligning pharmaceutical enterprises is a curious perennial dance, one that becomes even more active during presidential campaign seasons.  That always struck me as odd, since it seems a sign of societal advance that we can complain about the price of something that saves lives and improves living conditions rather than lamenting its nonexistence.

Regardless, the U.S. Chamber of Commerce’s Global Intellectual Property Center (GIPC) offers an instructive corrective entitled “4 Charts Explain the Economics of Drug Development.”  It is worth the brief examination and passing on to others, because it helps rebut many of the politicized myths that threaten the goose that lays the golden eggs:

“It’s not just the science that goes in to developing medicines that’s complicated.  The economics that drive the industry, allowing resources to be available so people can have access to beneficial new medicines is complicated, too.”

Each chart is worth 1,000 words, but the four broad takeaways are:  (1)  It takes ten years and $2.6 billion to bring a single drug to market;  (2)  In 2014, pharmaceutical companies spent $51.2 billion on research & development;  (3)  Only a few drugs, however, become commercial successes;  and (4)  The end result is that pharmaceuticals’ enormous investments result in people living longer and better lives.

Something to keep in mind as sometimes silly presidential campaigns get even sillier, at least in terms of maligning the innovative pharmaceutical industry.