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Addressing "Temporary" Insanity

  • 07.23.2021
  • Peter Pitts
I just googled “temporary vaccine waiver” under “news” and got 31,900 hits.

Then I ran the same exercise for “Pfizer and BioNTech Announce Collaboration with Biovac to Manufacture and Distribute COVID-19 Vaccine Doses within Africa.” I got 1300 hits.

That’s upside down and unfortunate since it’s the Pfizer/BioNTech announcement that’s going to save lives.

Here’s the rest of the story:

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union.

“We aim to enable people on all continents to manufacture and distribute our vaccine while ensuring the quality of the manufacturing process and the doses”

Biovac will perform manufacturing and distribution activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network, which will now span three continents and include more than 20 manufacturing facilities. To facilitate Biovac’s involvement in the process, technical transfer, on-site development and equipment installation activities will begin immediately.

Pfizer and BioNTech expect that Biovac’s Cape Town facility will be incorporated into the vaccine supply chain by the end of 2021. Biovac will obtain drug substance from facilities in Europe, and manufacturing of finished doses will commence in 2022. At full operational capacity, the annual production will exceed 100 million finished doses annually. All doses will exclusively be distributed within the 55 member states that make up the African Union.
“From day one, our goal has been to provide fair and equitable access of the Pfizer-BioNTech COVID-19 Vaccine to everyone, everywhere,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Our latest collaboration with Biovac is a shining example of the tireless work being done, in this instance to benefit Africa. We will continue to explore and pursue opportunities to bring new partners into our supply chain network, including in Latin America, to further accelerate access of COVID-19 vaccines.”

“We aim to enable people on all continents to manufacture and distribute our vaccine while ensuring the quality of the manufacturing process and the doses,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We believe that our mRNA technology can be used to develop vaccine candidates addressing other diseases as well. This is why we will continue to evaluate sustainable approaches that will support the development and production of mRNA vaccines on the African continent.”

“We are thrilled to collaborate with Pfizer and BioNTech to produce and distribute the Pfizer-BioNTech COVID-19 Vaccine within Africa. This is testament of the long-standing relationship we have had with Pfizer through the Prevenar 13 vaccine,” said Dr. Morena Makhoana, CEO of Biovac. “This is a critical step forward in strengthening sustainable access to a vaccine in the fight against this tragic, worldwide pandemic. We believe this collaboration will create opportunity to more broadly distribute vaccine doses to people in harder-to-reach communities, especially those on the African continent.”

Pfizer and BioNTech select contract manufacturers using a rigorous selection process based on several factors: quality, compliance, safety track record, technical capability, capacity availability, highly trained workforce, project management abilities, prior working relationship, and commitment to working with flexibility through a fast-paced program. Pfizer and Biovac have worked together since 2015 on the sterile formulation, fill, finish and distribution of the Prevenar 13 vaccine.

To date, Pfizer and BioNTech have shipped more than 1 billion COVID-19 vaccine doses to more than 100 countries or territories in every region of the world. The companies are firmly committed to working towards equitable and affordable access for COVID-19 vaccines for all people around the world, actively working with global governments as well as global health partners with the aim to provide 2 billion doses to low and middle income countries in 2021 and 2022 – 1 billion each year. This includes an agreement to supply 500 million doses to the U.S. Government at a not-for-profit price, that the government will, in turn, donate to the African Union and the COVAX 92 Advanced Market Commitment (AMC) countries, as well as a direct supply agreement with the COVAX facility for 40 million doses.
The “Right to Repair” issue pertains to FDA-regulated medical devices and the unintended negative consequences for patient health and safety that would result if unregulated third-parties were allowed to work on these highly sophisticated pieces of equipment.

“Right to repair” advocates point to FDA’s 2018 report they claim led the agency to “take a pass” on regulating third party device servicing because they could find no evidence of a problem. Cheery-picked quotes describe third-party servicers as providing “high quality, safe, and effective servicing of medical devices … critical to the functioning of the U.S. healthcare system.”

This is out of context, wrong and dangerous. The fact of the matter is that the FDA report said the agency didn’t have enough data to make a definitive conclusion about third party servicing. The FDA doesn’t have that data because unregulated servicers aren’t required to register with the agency and FDA can’t even establish how many third-party servicers are actually out there – though the agency estimates there are between 16,000 - 21,000.

Further, the FDA’s 2018 report showed the majority of inadequate services reported should actually be categorized as remanufacturing, meaning that the device in question is no longer the device the FDA gave clearance/approval to. Big difference. Big problem.

In truth, the agency laid out a roadmap to address this issue and has been executing against it over the last several years through remanufacturing guidance and cybersecurity discussion papers. This is where the FDA should concentrate its efforts: educate, surveil and enforce actions on remanufacturing to ensure service activity doesn’t cross over into regulated activity.

On July 27, the FDA is holding a public meeting on this topic. It couldn’t come at a better time. The proper servicing and security of medical devices and other health care technologies mustn’t be allowed to be undermined by third-party servicing apologists willing to employ bad faith tactics and misrepresent the facts.
The other week, the HHS Inspector General released a report about just how little oversight the Medicare program has over medical device cybersecurity (and what little discretion is does have, it rarely uses).

If you’ve been following the news lately, you’ll know that cybersecurity in the healthcare space is a big problem. Hospitals and health systems large and small have increasingly been on the receiving end of hacks, cyber-attacks and ransomware intrusions. Not to mention that an estimated 275 million medical images are currently vulnerable due to unsecured picture archiving communication systems.  HHS just released another alert about that just days after the Inspector General report came out.

The report focused on the role of Medicare accrediting organizations’ failure to keep proper tabs on whether hospitals were maintaining proper cybersecurity of their networked devices. According to the report: 

CMS’s survey protocol does not include requirements for networked device cybersecurity, and the AOs [accrediting organizations] do not use their discretion to require hospitals to have such cybersecurity plans. However, AOs sometimes review limited aspects of device cybersecurity.

For example, two AOs have equipment maintenance requirements that may yield limited insight into device cybersecurity.  If hospitals identify networked device cybersecurity as part of their emergency-preparedness risk assessments, AOs will review the mitigation plans. AOs told us that in practice, however, hospitals did not identify device cybersecurity in these risk assessments very often

But most importantly, the OIG’s report underscored the lopsided cybersecurity expectations in the healthcare industry. Cybersecurity is supposed to be a shared responsibility between device manufacturers and providers. For their part, the manufacturers are tightly regulated by the FDA and are required ensure their products are secure through a carefully designed protocols subject to frequent updates. Alas, the best-designed devices in the world can’t compensate for negligence or poor practices on the part of the end-user.

Which brings me to the point I raised in The Hill recently about how unregulated medical device servicing poses serious risks for cybersecurity. Original equipment manufacturers and their servicers are regulated by the FDA. Third party servicers – who could really be anyone since there are no universal training and licensing requirements to service these devices either – are not. Third-party servicers claim they’re held to the same standards as OEMs due to hospital accreditation. The OIG report flies in the face of that claim.

If the goal is to get rid of the “blind spots” that lead to cybersecurity incidents, ensuring that those who control repairs and maintenance of these highly sophisticated pieces of health care technology are FDA-regulated makes the most sense to me. Hiding behind accreditations that Medicare isn’t watching doesn’t. It’s clear no one is watching the proverbial coup on the hospitals’ end.

If hospitals and imaging providers can’t keep tabs on their own cyber security, how can we expect them to handle the servicing of highly sophisticated medical devices?
According to the U.S. PIRG, “Manufacturers of ventilators, dialysis machines and other critical medical devices routinely restrict access to essential repair materials. That leaves hospital repair technicians, commonly known as biomeds, without the tools they need to fix medical equipment as soon as it breaks. Instead, they have to wait days, weeks or even a month for a manufacturer-branded technician to travel onsite and make the repair well within the biomed’s capabilities. In the meantime, that broken ventilator can’t be used to deliver life-saving treatment to a patient.”

As my grandmother used to say, “A half-truth is a whole lie.”

At first glance, “Right-to-Repair seems like a good idea. Why not make it easier for consumers to fix their broken electronics, without having to pay a costly sum to the original manufacturer? But, as HL Mencken reminds us, “For every complex problem there is an answer that is clear, simple, and wrong.” The reality is that Right-to -Repair presents many dangerous unintended consequences. The Number One problem is that it compromises patient safety.

The core of Right-to-Repair laws is to require innovative technology companies to make product repair information, replacement parts, and tools readily available to consumers and third-party repair shops. Should that be the case for devices such as Automated External Defibrillators and hospital ventilators? What about electrocardiograph (ECG) machines? Can physicians and patients be confident in non-FDA compliant vendors without the advanced training and technical ability to properly repair and recalibrate life-saving machines? Who could argue that “anyone can do it?”

Well – U.S. PIRG for one.

By allowing third parties without any FDA competence to repair regulated, complicated medical devices, Right-to-Repair also opens the door to breaches in cybersecurity. According to the FDA, “Cybersecurity is a widespread issue affecting medical devices connected to the Internet, networks, and other devices. Cybersecurity is the process of preventing unauthorized access, modification, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient.”

In a recent FDA discussion paper, “Strengthening Cybersecurity Practices Associated with Servicing Medical Devices: Challenges and Opportunities,” the agency asks, “How can entities that service medical devices contribute to strengthening the cybersecurity of medical devices?” According to the discussion paper, “FDA defines service to be the repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety and performance specifications established by the original equipment manufacturer (OEM) and to meet its original intended use.” In other words, the first step in advancing medical device cybersecurity is to limit and ensure that those who control repairs and maintenance of these highly sophisticated pieces of healthcare technology are regulated FDA manufacturers.

On July 27th, the FDA is holding a public meeting on this topic. It couldn’t be timelier. The proper servicing and security of medical devices and other healthcare technologies is too important for uniformed posturing. U.S. PIRG should know better.


Speaker Pelosi's Mistaken HR 3-Peat

  • 04.22.2021
  • Peter Pitts
Word on the street is that H.R. 3 is going to be reintroduced today.

New Congress. Same bad ideas. A hit parade of bad ideas.  For example:

An International Pricing Index. Patients often lose access to the best medicines when their government adopts price controls. Of the drugs launched in the last seven years, only 60% were available in Sweden. And only half made it to patients in Canada. In the United States, meanwhile, nearly 90% of those medicines were available. Americans will no longer enjoy generous access to the newest drugs if we embrace price controls. Importing the socialist pricing tactics of foreign governments is no way to stand up for Medicare patients. Bad idea when it comes from the White House, Bad idea when it comes from the People’s House.

Direct Government Negotiation. Is the direct federal negotiation of drug prices a good idea? Consider the “non-interference clause” that currently prohibits such actions in Medicare Part D — the federal program that subsidizes prescription drugs for seniors. A repeal of the non-interference clause would result in a sharp increase in Medicare drug prices and a substantial decline in patient choice.

The Congressional Budget Office observed that Part D plans have “secured rebates somewhat larger than the average rebates observed in commercial health plans.” According to the CBO, to achieve any significant savings, the government would have to follow through on its threats of “not allowing [certain] drug[s] to be prescribed.” In other words, the government would drop some drugs from Medicare’s coverage to save money. That would be a raw deal for patients. The average Part D plan provides access to more than 95 percent of the top 200 Medicare Part D Drugs. (PS/ The Non-Interference Clause was written by Senators Ted Kennedy and Tom Daschle.)

Rebates to Off-Set Price Hikes. When Americans say, “My drugs are too expensive,” what they generally mean is that their co-pays at the pharmacy are too expensive. And they’re right. But co-pays aren’t tied to list prices. Consider this: payers negotiate discounts of between 30-50% of the list price – and then base the co-pay off of the list price. What happens to the discount? They pocket the difference. When payers say that higher co-pays are a result of higher list prices they are lying. Surprisingly absent from H.R. 3 is any call for pricing transparency. Shameful.

The primary difference from the previous version is that this “new” itereation will not specify how the funds will be used – Speaker Pelosi’s goal is to use this as a pay-for in the American Family Act

H.R. 3 is a cruel joke. Cruel to patients.

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 mcoluccio@cmpi.org.

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. 


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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