Latest Drugwonks' Blog

New CMPI Book: The Value Equation

  • 01.07.2021
  • Peter Pitts
The Value Equation Charts Pathway for 21st Century Medical Innovation
Former FDA Associate Commissioner Details Urgency of Advancing the Healthcare Ecosystem

In his new book, The Value Equation: A Journey Through the Innovation Ecosystem in the Time of COVID, Peter Pitts argues that healthcare innovation saves lives, saves money, promotes economic growth, and provides hope for hundreds of millions of people (both patients and care-givers) in the United States and around the world. But that innovation isn’t easy and the path forward is neither smooth not brightly lit.

The Value Equation features essays by Pitts and a host of experts covering a wide range of “urgencies” including the urgency of innovation, quality, information sharing, 21st century medicines regulation, safety, the evolving patient voice, value-based healthcare technology assessment and the lessons learned from COVID-19.

According to Professor Pitts, President of the Center for Medicine in the Public Interest, a Visiting Professor at the University of Paris Descartes School of Medicine and a former FDA Associate Commissioner, “There are many roadblocks beyond those of discovery and development. The complicated and conflicting dynamics of politics, perspectives on healthcare economics, of friction between payers, providers, manufacturers, and regulators, the battle for better patient education, and the need for a more forceful and factual debate over the value of innovation all create the need for a more balanced and robust debate.”

“Excellence,” wrote Aristotle, “is never an accident. It is always the result of high intention, sincere effort, and intelligent execution; it represents the wise choice of many alternatives. Choice, not chance, determines your destiny.” The Value Equation address many of these choices – and their consequences.

The Value Equation: A Journey Through the Innovation Ecosystem in the Time of COVID is necessary reading for anyone interested in charting a new, urgent path forward for patient-centric healthcare innovation.

To speak with Peter Pitts or receive a copy of The Value Equation: A Journey Through the Innovation Ecosystem in the Time of COVID, please contact Mario Coluccio at

The Dangers of Foreign Entanglements

  • 11.23.2020
  • Peter Pitts
CMS anticipates one implication of the President’s insistence on foreign price controls is that Medicare beneficiaries will lose access to medicines because of the policy:

“While there are significant savings as a result of this model, a portion of the savings is attributable to beneficiaries not accessing their drugs through the Medicare benefit, along with the associated lost utilization. This estimate does not capture any impacts to other program costs as a result of lower utilization.”

This rule is bad not only for the future of healthcare innovation but also for patient outcomes.

Actions have consequences.
UnitedHealthcare is demanding that HCPs rat out their patients who are using copay coupons. Per a letter sent by United Healthcare to HCPs, “Effective 1/1/21 providers must submit specialty medication medical claims and manufacturer copay coupon reimbursement information to UnitedHealthcare.”

By way of explanation, UH offer the following:

“In order to align employer costs for specialty medications with actual member out of pocket and deductibles, UnitedHealthcare is launching the Accumulator Adjustment Medical Benefit program. This program requires providers to submit patient information received from drug manufacturer copay coupon programs which are applied to a member’s cost share when billing for specialty medications as a medical benefit drug claim.”

That’s right, UH has the chutzpah to refer to this as a “medical benefit program." Talk about a large dose of Orwellian NewSpeak. Shame on UH for behaving like a 21st century Stasi.

(With a big hat tip to Adam Fein over at Drug Channels.)

An Importation Poison Pill

  • 09.25.2020
  • Peter Pitts
Meanwhile back at the ranch – drug importation.

In the midst of a global pandemic, a Presidential election and a Supreme Court vacancy the FDA has issues its “Safe Importation Action Plan.”

Per the FDA press release:

The final rule implements a provision of federal law that allows FDA-authorized programs to import certain prescription drugs from Canada under specific conditions that ensure the importation poses no additional risk to the public’s health and safety while achieving a significant reduction in the cost of covered products to the American consumer.

The FDA spells out two pathways.

Under Pathway 1, a Notice of Proposed Rulemaking (“NPRM”) would rely on the authority in the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) section 804 to authorize demonstration projects to allow importation of drugs from Canada. The NPRM would include conditions to ensure the importation poses no additional risk to the public’s health and safety and that it will achieve significant cost savings to the American consumer.

Under Pathway 2, manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same as the U.S. versions. Under this pathway, manufacturers would use a new National Drug Code (NDC) for those products, potentially allowing them to offer a lower price than what their current distribution contracts require.

Assuming that Pathway 2 is a non-starter, let’s have a look at some key codicils of Pathway 1:

Non-Eligible Drugs: The NPRM would restate the exclusions listed in section 804(a)(3); namely, controlled substances, biological products, infused drugs, intravenously injected drugs, drugs inhaled during surgery, and certain parenteral drugs would be excluded from this pathway. The NPRM would additionally exclude any drug with a REMS.

The NPRM will help address this issue by requiring applicants to demonstrate how they will. comply with: track and trace requirements to allow drug tracing from manufacture to pharmacy; certain labeling requirements to ensure the imported drugs meet all labeling requirements of the FD&C Act; requirements to ensure foreign sellers engaged in the distribution of the imported drugs are registered;  importation entry requirements (e.g., providing certain electronic information demonstrating that each shipment should be allowed into the U.S.); and post-importation requirements such as adverse event reporting, procedures to facilitate recalls, and cGMP for certain manufacturing activities such as relabeling.

Cost Requirements: The NPRM would explain the requirement for demonstrating that drugs imported under this pathway must result in a significant reduction in the cost of covered drug products to the American consumer. As such, the NPRM would seek feedback on the best way to identify the expected acquisition cost of the imported drug, the cost of assuring the drug is safely imported, and the mechanism for delivering those savings to the consumer (as opposed to the savings being absorbed by the supply chain).

Transparency: The NPRM would require some indication in the labeling that drugs imported under this program were originally intended for distribution in Canada. In particular, the NPRM would seek comment on requiring that the label include the NDC, part of which would be unique to drugs imported under this program.

One item of importance not addressed in the agency’s plan is whether or not the Canadian government will change its position and allow American importation programs. That’s more than a minor detail. Canadian officials have already stated that “Canada does not support actions that could adversely affect the supply of prescription drugs in Canada and potentially raise costs of prescription drugs for Canadians.”

If Ottawa maintains its no-go policy, it’s an importation poison pill.


The End of the Era of Smoking?

  • 09.23.2020
  • Robert Goldberg
Since becoming Juul’s CEO in 2019, K.C Crosthwaite has cut the company’s workforce in half and pulled most of its well-known e-cigarette products off the market, thereby deliberately cutting sales.

To Crosthwaite that’s progress.  Juul’s rapid growth was the target of got anti-smoking groups, suburban moms terrified their kids – who were getting high and drinking with parental foreknowledge if not consent – would become addicted to nicotine and media coverage that framed Juul as a trojan horse for increased cigarette use.   

Slowing down and paring back growth is tied to Crosthwaite’s goal of building up a body of evidence demonstrating that the use of the device reduces the harm of smoking.  Most critically, in August “Juul submitted a Premarket Tobacco Product Application (PMTA) for the JUUL device as well as its Virginia Tobacco and Menthol flavored JUULpod.”

As part of that submission, JUUL has provided data on the persistence and rates of switching to their product from cigarettes.  It turns out that 43 percent of dual users (people who smoke cigarettes and use JUUL devices) switched entirely to an e-cigarette over a 12-month period.  

Additionally, JUUL has been monitoring the effect of programs it has in place to limit and reduce underage use of its products. JUUL has generated real-world evidence demonstrating that uptake by people 21 and younger declined.

Speaking at the (virtual) Global Tobacco & Nicotine Forum (GTNF) Crosthwaite noted that the emergence of non-combustible products has created a historic opportunity to drive down cigarette use around the world.  Unfortunately, most public health agencies are outlawing or limiting e-cigarette sales while allowing tobacco sales to continue.  The same agencies have made a point of inflating and identify the risks of e-cigarettes so that most consumers think they are riskier than tobacco.  No wonder that cigarette consumption has been increasing, a trend that began before the pandemic and continues even now. 

As Crosthwaite pointed out, the rebound in cigarette sales due to the fearmongering and counterproductive regulation of non-combustible nicotine products increases the risk of tobacco-related death and disease.  Let’s hope the PMTA process can be used to move past such obstacles so that we can continue to eradicate smoking from the planet. 


My interview with Seqster CEO Ardy Arianpour on how his company's platform for generating personal health records solves the interoperability and data assess challenges. 

Are We Suffering From COVID Overreaction??

  • 08.17.2020
  • Robert Goldberg
Per Congressional mandate, the FDA has submitted a report to Congress on the state of the CBD marketplace.

The report outlines studies the agency has performed on the contents and quality of cannabis-derived products that it has tested over the past six years. As predicted in my testimony at the FDA’s June 2019 Part 15 hearing, there is significant inconsistencies between cannabinoids concentrations that are listed on labels and what the products actually contain.  Some relevant verbatims from the FDA report:

“FDA recognizes the significant public interest in CBD products,” the agency wrote. “However, there are many questions about the characteristics of currently marketed CBD products because the Agency lacks significant information on what CBD-containing products are on the market and there are little data available on those products themselves.”

“FDA believes that understanding the characteristics of marketed CBD products is critical to making informed decisions about how best to protect public health in the current marketplace."

“Of the 102 products that indicated a specific amount of CBD, 18 products (18%) contained less than 80 percent of the amount of CBD indicated, 46 products (45 percent) contained CBD within 20 percent of the amount indicated, and 38 products (37 percent) contained more than 120 percent of the amount of CBD indicated.”

Only one of 133 samples had potentially hazardous materials.

Well – that’s reassuring.

FDA is undertaking a more extensive CBD product testing effort that will involve using “a sampling methodology to create a representative, random sample of the current CBD product marketplace.”

“The Agency is purchasing data on brands, product categories, and distribution channels for CBD products.” The FDA is also “in the process of developing its own comprehensive list of brands operating in the CBD market space by assembling data from targeted internet searches and analytics. FDA intends to leverage both data sets to randomly sample products across brands, product categories, and distribution channels, while favoring products with a higher market share.”

The sampling is expected to cover cannabis tinctures, oils, extracts, capsules, powders, waters and other beverages, food items, cosmetics, personal lubricants, tampons, vape cartridges and products sold for pets.

It is unlikely the FDA’s bark will be worse than its bite.

Per the FDA, “Together, this information will provide the Agency with a better understanding of product characteristics in the current CBD marketplace and will help protect and promote public health.”
A new study out of the Bay State regarding the importance of copay assistance programs and the downside of accumulators. 

The Massachusetts Health Policy Commission (HPC) examined copay accumulators and the use and impact of prescription drug coupons in Massachusetts.  (The Massachusetts HPC is an independent state agency charged with monitoring health care spending growth in Massachusetts and providing data-driven policy recommendations regarding health care delivery and payment system reform.)
Of note, the study finds that, “Continued growth in high deductible plan enrollment, coupled with increasing drug prices, suggests that patient affordability challenges will only increase. Eliminating the availability of coupons at this time – without substantial protections for patient affordability – would likely create serious challenges for many patients in the Commonwealth.” 
As to copay accumulators, “they are unlikely to encourage patients to use lower cost alternatives. Copay accumulators shift costs from the payer to the manufacturer and patient, potentially resulting in lower premiums. However, copay accumulators may preserve the affordability challenges that patients originally faced in their plan design, which could lead to lower access and adherence. In addition, these programs may increase administrative complexity for payers and PBMs and add confusion to patients navigating an increasingly complicated health care system.”
Facts are stubborn things; and whatever may be our wishes, our inclinations, or the dictates of our passion, they cannot alter the state of facts and evidence – John Adams

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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