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FDA Commissioner Scott Gottlieb Wednesday called on branded drug companies to “end the shenanigans” they use to block generic competition, and announced new steps to rein in some anticompetitive practices.

Speaking at a Federal Trade Commission meeting on competition in prescription drug markets, Gottlieb noted that drug companies sometimes prolong negotiation over terms of a shared REMS as a tactic to delay approval of generic drugs. To counter such practices, he said FDA is making it easier for sponsors of innovative drugs to cooperate with generic companies to implement a common master file for the implementation of a REMS.

The common REMS master file is a “first step toward making it easier to implement a single shared REMS,” Gottlieb said.

FDA published draft guidance entitled “Use of a Drug Master File for Shared System REMS Submissions” in the Federal Register Wednesday.

While a shared REMS will make it easier for providers to comply with the risk mitigation programs, they can also be used to prevent drug companies from prolonging negotiations with generic companies, Gottlieb said. “Our goal is to see sponsors share REMS systems to reduce burdens on providers. But when branded drug makers drag out these negotiations -- sometimes as a way to forestall generic entry -- we’re going to be in a stronger position now to say enough is enough.”

If branded companies fail to agree on terms of a shared REMS, FDA will “have a stronger basis to issue a waiver that will allow the generic drug makers to go their own way if they have to, and develop their own REMS,” he said at the FTC meeting. In a statement issued to media, Gottlieb said FDA plans to provide more information on how and when generic companies can request a shared REMS waiver and the factors FDA intends to consider.

At the meeting, Gottlieb also vowed to use FDA’s bully pulpit to deter supply chain intermediaries like specialty pharmacies from helping pharma companies deny generic manufacturers access to samples that are needed to conduct FDA-required tests. Gottlieb said he is “going to contact pharmaceutical supply chain intermediaries to inform them of the FDA’s interest in making sure that generic firms can gain access to the doses they need to run bioequivalence studies. When intermediaries sign on to these restrictive games, I want them to know that they’re challenging a broader public health goal.”

Gottlieb made a public health case for competitive drug markets. “Our economic model, which rewards highly innovative drugs with the opportunity to hold monopolies for a limited period of time through patents and exclusivities, and to freely price their products to a measure of the value that a transformative drug offers, also depends on the generic approval process working as intended,” he said. “It depends on the ability to have vigorous competition once those patents and exclusivities have lapsed.”

Comments on the draft guidance are due in 60 days.
David Mitchell, the fact-challenged founder of Patients for Affordable Drugs has never been one to spend more than a nanosecond with the truth when it comes to discussing the value of medical innovation. 

He also is allergic to being transparent about his background and funding. Either that or he is exceedingly modest.   Mitchell is speaking at an FTC meeting entitled, “Discussion: Potential Next Steps to Encourage Entry and Expand Access through Lower Prices."

Here's his bio for that event:

David has 40 years of experience working on health care and public health policy as a communications specialist. He has worked to reduce teen smoking, increase use of seat belts, to fight drunk driving and improve child health and safety. He helped build and run for more than 30 years GMMB—a cause-oriented, public policy communications firm in Washington, DC. He retired in 2016 to focus his full energy and attention on helping bring about policy change to lower drug costs. You can follow him on Twitter here. Email him at

Here's what he left out: 

Received nearly $60 million in federal contracts after Obama took office, according to an analysis by The Daily Caller News Foundation Investigative Group.

$200 million from the Clinton campaign in 2016 and $389 million from the Obama campaign in 2012

$12 million from Phrma to run pro-Obamacare ads

Nearly $700 million to promote Obamcare enrollment. 

My favorite: $575K to run ads in Jewish news outlets in support of the Iran nuclear deal.

These tidbits are important because it provides some clues about why David would get $500K from the Laura and John Arnold Foundation to set up a patient group. 

Indeed, it is curious that in his FTC bio, David left out important background information about his group.   Patients For Affordable Drugs claims it " is the only independent national patient organization focused exclusively on achieving policy changes to lower the price of prescription drugs."

First, it is not independent.  It receives 87 percent of its funding from one source:  the aforementioned Laura and John Arnold Foundation (LJAF).  Second, it cooperates and coordinates with other LJAF grantees including ICER and Harvard's Aaron Kesselheim.  ICER mind you have deemed most new cancer drugs marginally effective and too expensive despite evidence to the contrary.  Have you heard P4AD challenge ICER?  You haven't and you won't because they get cash from the same cow. Third, Mitchell's funding is never disclosed when media outlets that also receive LJAF money to run stories about drug prices quoting him.  That's deliberate. 

Further, it is NOT true that it is the only group pushing for lower drug prices.  On the contrary, many other patient organizations who, in addition to providing counseling, funding basic research and covering expenses for cancer patients, have pushed for policies that would reduce the time and cost of drug development and promote generic competition.  P4AD is silent on accelerating innovation at the FDA.  Moreover, while other groups have fought for caps on drug copays, the elimination of step therapy, passing rebates directly to patients, PFAD has paid lip service to these issues. 

It is simply a media outlet for dog whistle messaging about drug prices.  Mitchell loves to say he is grateful for medical innovation as a myeloma survivor.  But many would argue (including me) that the policies he is promoting have been proven to marginally reduce prices but substantially limit access and future innovations.  

Nobody disagrees with the goal of reducing health care costs and drug prices.  But P4AD is a hollow advocacy group that does nothing to advance FDA and reimbursement reforms to would make new medicines less expensive and more affordable.  By excluding the Arnold affiliation and GMMB's main revenue sources, David is trying to portray himself as a lonely crusader against big Pharma.   There's very little truth in that depiction. 


Taxing Orphans

  • 11.03.2017
  • Peter Pitts
How do you spell "mistake?"

The new tax bill would eliminate tax credits used to develop rare-disease drugs. Currently, drug makers get allowed a tax credit of up to 50 percent of certain research costs for rare-disease drugs. The new tax bill would repeal the credit, which falls under the Orphan Drug Act, “for certain drugs, for rare diseases or conditions” starting after this year.
An op-ed I was honored to co-author with BIONJ's CEO, Debbie Hart.    

Article was originally published in the New Jersey Spotlight
You can learn more about BIONJ here

Insurance companies often use value frameworks to steer all patients to the least-expensive products, erecting barriers to obtaining recommended treatments

There’s been a lot of discussion about using “value frameworks” to reduce the cost of drugs and increase patient access. Value frameworks are being proposed as tools to determine which medicines will be covered, reimbursed, and made available to patients. Value-assessment frameworks attempt to assess therapeutic options based on clinical benefits, health outcomes, value to the patient, and effectiveness, compared with other potential treatment options … all in the context of cost.  Unfortunately, such evaluations assume that on average, everyone will respond to all drugs in the same way. In fact, the same treatment can have different benefits to different patients, depending on their genetics, combination of diseases, severity of illness, age, gender, and race.   

Moreover, value frameworks are used by insurance companies to steer all patients to the least-expensive products by imposing higher cost-sharing and more barriers to obtaining recommended treatments, even if the other drugs are not as effective or oftentimes, don't work. Coverage is already constrained through higher out-of-pocket spending, and step therapy (a patient must fail first on medicines specified by the insurance company before being eligible to receive the drug actually prescribed by the physician), and prior authorization. 

In addition, value frameworks, by limiting choice further, make it even more difficult to match people to the treatments that work best. And by measuring value simply in terms of reducing other healthcare spending, such frameworks are biased against the most vulnerable patients with few or no treatment options. Not every medicine will save money, but most medicines for people with rare, life-threatening, or disabling conditions improve the quality of life. In many instances, the first new treatment allows people to enjoy the opportunity for the next round of therapy that in turn, may increase well-being and save lives.

As Mark Fendrick, the godfather of value-based health insurance has stated, “the sickest patients are often those who face the highest financial burdens and the greatest obstacles to access.” Where is the value there?

That is not to say that the cost and benefits of new products should escape scrutiny. BioNJ welcomes the opportunity to discuss the true value of medical innovation and demonstrate the importance of enabling meaningful access to innovative medicines that benefit the entire healthcare system, the economy, and society as a whole. 

Long-term impact
But value frameworks ignore the long-term impact of new medicines in setting prices and rationing access. The formulations being used do not take into consideration that increasing the number of healthy people working, going to school, investing, and contributing to society will actually save healthcare costs and ensure a robust insurance system. 

We need healthcare coverage that concentrates on improving quality of life and averting loss of productivity and capability due to disease. Drug prices should reflect the differentiated worth of specific features or benefits that a new treatment provides and the ability to invest in future innovative medicines. This approach will encourage increased access and lower costs based on a new medicine's value and quality.

For example, Celgene CEO Mark Alles recently wrote that his company is “proactively working with major commercial U.S. healthcare payers on arrangements designed to give eligible patients access to our most recently approved medicine — a precision therapy with an accompanying diagnostic test — without deductibles, co-pays, and co-insurance. By partnering with payers to offset and even eliminate patient cost sharing as an obstacle to treatment, our hope is to prevent some of the financial burden that leads to many of the problems currently impacting patient care.”

For BioNJ, ensuring that “patients have the right treatment at the right time” for the greatest benefit is not just a slogan: It’s our vision. We owe it to patients to provide access to innovative medicines that are transforming the trajectory of many debilitating diseases and conditions.  

Consider that over the past 30 years U.S. cancer survivors have more than doubled to 14.5 million. HIV/AIDS — once a death sentence — is now a chronic manageable condition. Deaths from heart disease have declined by 50 percent. More recently, hepatitis C, once an incurable disease, can now be cured with one pill a day taken over four months.

In the absence of those medicines, healthcare would be more expensive, fewer people would be alive, and more people would live in pain.

That’s why with nearly 70 percent of medicines in the pipeline, potentially first-in-class therapies, the promise for increased life expectancy, improved life quality, and reduced healthcare costs is boundless. Because Patients Can’t Wait, BioNJ looks forward to working with insurers, consumers, employers, elected officials, physicians, and biopharma companies to speed the right medicines to the people who need — and will benefit from — them the most. Now that’s a patient-centered value framework!

Debbie Hart is president and CEO of BioNJ. Robert Goldberg, Ph.D., is vice president & co-founder of the Center for Medicine in the Public Interest.

In testimony as the nominee to be Secretary of the Department of Veterans Affairs, Dr. David Shulkin promised: “There will be far greater accountability, dramatically improved access, responsiveness and expanded care options…. If confirmed, I intend to build a system that puts Veterans first and allows them to get the best possible health care wherever it may be – in VA or with community care.”
Sadly, less than five months into his appointment, Dr. Shulkin’s promise was broken when The VA’s Pharmacy Benefits Management Services office (PBMS) started partnering with The Institute for Clinical and Economic Review(ICER) set drug prices and limit veteran access to new medicines. 

According to ICER, the VA PBMS will use its “drug assessment reports in drug coverage and price negotiations with the pharmaceutical industry.”  But given ICER’s disregard of how patient’s value medicines the partnership has generated legitimate concern

The program’s directors - C. Bernie Good, Tom Emmendorfer and Michael Valentino recently churned out an incoherent and fact-free response to criticism of the partnership on the Health Affairs blog.  They defended the ICER partnership as contributing to the VAPBMS unsurpassed ability to provide the best medicines at the lowest cost.   They also claimed, with a straight face, that the VA health system provides better care than any other place.   As anyone who has read the book "Thank You For Your Service" or seen the movie version knows, quite the opposite is true.  And frankly, the "everything is perfect" tone of their blog suggests that they are more interested in sucking up to professional critics of the pharmaceutical industry then they are in helping making wounded warriors whole.  

In fact, ICER and VAPBMS are clearly more interested in using the VA as a model for determining drug prices and access nationwide.    The authors insist ICER evaluations will only be used to help the VA  authors set prices for new drugs.  That's nonsense.  The VA pharmacy benefits program already sets prices and restricts access to new medicines.  Under federal law, drug companies must the VA a price at least 24 percent lower than the best private sector price.  They also must give the VA rebates if prices go up more than inflation.   

So what is ICER's role likely to be? The authors assert that as “a federal organization, the VA lives within the reality of a fixed annual budget. Money spent well for high-value drugs (regardless of the overall individual cost of that drug or technology) is a good thing.” 

But that is not how the VA or ICER approaches access to new medicines. Apart from mandated price controls, the VA excludes some drugs and not others to get additional discounts.  This is an approach ICER has supported since its existence.  

Despite the authors' support of high-value medicines, the VA as consistently limited access to them at a great cost to patients.  A study by economist Frank Lichtenberg found that not only were 20 percent of drugs approved since 2000 covered by the VA and that the limited access was associated with lower life expectancy over age 65 compared to Medicare.  The innovation gap has grown since then.  Less access means more death. 

Indeed, since Lichtenberg did his study, the innovation access gap has gotten worse. A recent Avalere study found that "The VA National Formulary covers 54 percent of drugs on the California public employee retiree plan formulary, including 46 percent of brand drugs (102 of 222) and 61 percent of generic drugs (174 of 287.) " And it covers 50 percent few medicines than most state Medicaid plans. 

Yet, the authors claim lots of people get access to drugs not covered under the VA formulary.  Also, untrue. Getting a drug that is not on the formulary is difficult.  Most reviews are denied and over half take two weeks to process.  Veterans often have to travel hundreds of miles to get the medicine from a VA pharmacy.  

Indeed, the Inspector General's audit of the death of a lung cancer patient at a VA Southern Nevada Health System found that” patient had to travel 30 miles each way from his home to a system clinic for pharmacist review and approval of his physical prescription. " It took 14 days to get an off-formulary medicine approved.  In the meantime, the patient had to pay $4000 out of pocket for drugs.

ICER will only make the VA’s denial of timely, effective treatment worse, if that’s possible.   In the past, ICER reports have been used to limit access to cures for hepatitis C, drugs that reduce the risk of heart attacks and a wide variety of medicines for people with rare cancers.   ICER’s estimate of the value of medicine is so low that many of the drugs used to treat HIV would have been rejected by the group. 

The authors claim that VA patients get faster and broader access to HCV drugs than commercial patients.  But until this year, the VA used the ICER guidelinesto limit access to a cure.    As a Newsweek article reported, a VA memo recommended treating those with advanced liver disease but holding off for patients with mild cases of the illness.  ICER’s recommendations are meant to save money, not save lives.  And when the VA started paying for drugs, cure rates went up.  

New medicines are what reduce the total cost of care and mortality. Price concessions and budget caps obtained by limiting access come at the expense of the most vulnerable and sickest people. If the VA uses ICER’s rationing scheme it will not only break Dr. Shulkin’s promise, it will darken and damage the lives of those veterans who need the VA the most.  


Utah's Importation Jazz

  • 10.26.2017
  • Peter Pitts
Per Ed Silverman over at Pharmalot:

Seeking a way to alleviate high drug prices, a Utah lawmaker hopes to introduce a bill that would allow the state to import prescription medicines from Canada, a move that is likely to accelerate a fierce debate over drug costs and patient safety.

Over the next several weeks, Rep. Norman Thurston, a Republican, plans to submit legislation to authorize state officials to designate an existing pharmaceutical wholesaler to purchase prescription drugs from a wholesaler in Canada. His hope is that retail pharmacies based in Utah would then be able to buy and sell medicines at lower prices.

“We’re still trying to work out some of the details, but we envision a safe supply chain that would result in significant cost savings for the citizens of Utah,” he told us. To allay safety concerns, he envisions the bill would require prescription medicines to be approved by regulators in both Canada and the U.S.

“And the bill would establish a chain of custody just like we have for U.S. distribution,” he said. “It shouldn’t be a significant cost to the state to set up a program, fill out paperwork and get approval (from the U.S. Human and Health Services secretary). According to federal law, that’s the only approval we need.”

Even so, the move is likely to receive considerable pushback.

In general, importation sparks debate that Americans could be exposed to counterfeit medicines.

Last year, four former Food and Drug Administration commissioners penned an open letter arguing against importation, citing such concerns. And the pharmaceutical industry has regularly lobbied against any and all efforts to allow importation. Over the years, Congress has failed to pass various bills that were proposed. And more than a decade ago, several states pursued web sites to allow residents to purchase medicines from Canada, but those efforts eventually sputtered, as well.

“Good luck with this. No HHS Secretary of either party has ever declared that importation is safe,” said Peter Pitts, a former FDA associate commissioner who heads the Center for Medicine in the Public Interest, a think tank that is funded, in part, by the pharmaceutical industry.
“We have a closed regulatory system. Health Canada may be world class, but it doesn’t mean we can have multiple standards for drug approvals. What matters is how a drug is manufactured, stored, and dispensed. It sounds easy, but is extraordinarily hard.”

For his part, Thurston is doggedly optimistic.

In this instance (as it generally is with schemes to advance importation, “doggedly optimistic” = “deaf and dumb to reality.”

Let’s cut right to the chase. Generic drugs (85% + of all medicines volume in the US are LESS expensive than in Canada or any European country. Next, for the overwhelming number of Americans with private health insurance, the co-pays for their products are LESS expensive then buying them retail at either a brick-and-mortar of Internet Canadian pharmacy. Biologics? 85% of all biologics are administered in hospitals. Is Senator Sanders suggesting that American hospitals should import drugs that may or may not have been shipped under proper refrigeration conditions? FDA inspections speak otherwise.

The on-the-ground reality of state and local importation schemes has been dismal and politically embarrassing. Remember Illinois’ high profile “I-Save-RX” program? Over 19 months, only 3,689 Illinois residents used the program—that’s .02 percent of the population.

And what of Minnesota’s RxConnect? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That’s in a state with a population of 5,167,101.

Remember Springfield, Massachusetts and “the New Boston Tea Party?” Well, the city of Springfield has been out of the “drugs from Canada business” since August 2006.

And speaking of tea parties, according to a story in the Boston Globe, “Four years after Mayor Thomas M. Menino bucked federal regulators and made Boston the biggest city in the nation to offer low-cost Canadian prescription drugs to employees and retirees, the program has fizzled, never having attracted more than a few dozen participants.”

The Canadian supplier for the program was Winnipeg-based Total Care Pharmacy. When Total Care decided to end its relationship with the city, only 16 Boston retirees were still participating.

Programs like this wouldn’t do any better on a national basis. A study by the non-partisan federal Congressional Budget Office showed that importation would reduce our nation’s spending on prescription medicines a whopping 0.1 percent—and that’s not including the tens of millions of dollars the FDA would need to oversee drug safety for the dozen or so nations generally involved in foreign drug importation schemes.

In addition to importing foreign price controls, Americans would end up jeopardizing their health by purchasing unsafe drugs while not saving money.

A better policy for our new President and Congress to focus on is the issue of increasing insurance company co-pays and co-insurance. Dropping drug co-pays would also help patients stick to their prescribed treatment regimes. All too often, people skip a dose, don’t get a refill, or stop taking their drugs prematurely in order to save money. In the long run, though, not adhering to a drug regimen leaves patients less healthy — and increases national medical expenses by an estimated $300 billion annually.

When consumers say, “My drugs are too expensive,” what they mean is that their co-pays and co-insurance are too expensive. And they’re right. Major insurance companies and pharmacy benefit managers (PBM) receive significant discounts from the manufacturers. So why doesn’t this result in lower co-pays for consumers? That’s a good issue for our new political leadership to debate – both in Salt Lake City and Washington, DC.

The Similarity Conundrum

  • 10.25.2017
  • Peter Pitts
Biosimilarity? No one said it was going to be easy.

A smart and timely cross-post from RAPS ...

Sandoz Raises Questions With FDA Draft Guidance on Statistical Approaches for Biosimilars

Martin Schiestl, chief science officer at Novartis' Sandoz, on Tuesday explained how the US Food and Drug Administration's (FDA) draft guidance on statistical approaches to evaluate analytical similarity poses risks that could end up causing true biosimilars to be rejected randomly.

Schiestl told attendees of DIA's biosimilars conference in Bethesda, MD, that the problem is related to equivalence testing, which FDA says in the draft, "is typically recommended for quality attributes with the highest risk ranking and should generally include assay(s) that evaluate clinically relevant mechanism(s) of action of the product for each indication for which approval is sought." 

The draft, released about a month ago, also notes: "Determining an appropriate margin is a critical but challenging step for equivalence testing in any setting. Ideally, it would be possible to establish and pre-specify a biologically or clinically meaningful equivalence margin based on scientific knowledge or past experience. Often, however, such a margin is not readily available for every quality attribute deemed important enough for Tier 1 testing in a biosimilar development program. With this limitation, FDA currently recommends use of an equivalence margin that is a function of the reference product's variability for the attribute being tested."

But Schiestl noted that monitoring the mean is useful in process development and post approval process monitoring.

However, for lot release decisions, "Compliance with a preset mean is an impossible criteria."

He added, "Strict adherence to equivalence testing for Tier 1 attributes makes biosimilar development a gamble. Justifications which may overrule a failed equivalence test should be added in the guidance."

Such justifications may include a scientific understanding of a variation and an "inconsistent mean of the reference product which might be caused by inherent process fluctuations within acceptable ranges, manufacturing changes or movements within a design space," Schiestl added.

Cigna Signals

  • 10.18.2017
  • Peter Pitts
Last week’s commentary on Cigna’s plan to replace Oxycontin ER with Xtampza ER on its core formulary (Is Cigna Trading Patient Choice for Hidden Profits?) resulted in a very open and honest chat with a senior Cigna executive. He assured me that patient co-pays wouldn’t go up for Xtampza ER and that if a patient stays on Oxycontin after prior authorization, that the co-pay would also stay the same. So, good news for patients there.

I asked how this change in tiering would “guard against opioid abuse” (since both products are formulated with properties designed to deter intranasal – snorting, and intravenous -- injection abuse, and one isn't "better" than the other). The answer was that, because of the value-based contract, Collegium would be rewarded for “appropriate prescribing.” But since Collegium (the manufacturer of Xtampza ER) doesn’t prescribe (they sell) would their role be in detailing “best practices?” The executive didn’t know -- but promised to get get back to me with an answer. So, watch this space for more details.

I also mentioned to him that Purdue Pharma (as far as I know) is the only company actively detailing the CDC Opioid prescribing guidelines. The CDC guidelines seem to be a baseline requirement for enhanced physician education, and who better to do this than the manufacturers who are detailing directly to them? While the process in the development of the guidelines was not as transparent as they could have been, the guidelines themselves are a sensible foundation. Hopefully Cigna’s deal with Collegium will drive better prescriber awareness.
From STAT News
Why do we need drug rebates, anyway? A top lawmaker wants to know

WASHINGTON — Sen. Lamar Alexander has a question: why do we have drug rebates, anyway?

“Why do we need rebates?” the Tennessee Republican asked a panel of pharmaceutical industry representatives at a Senate committee hearing. The Health, Education, Labor, and Pensions committee met Tuesday morning for the second of three hearings on drug pricing, and heard testimony from five interest groups representing companies that play different roles in getting medicines to patients.

Rebates are payments made by drug manufacturers to “pharmacy benefit managers,”  middlemen that negotiate drug prices on behalf of companies, unions, and government agencies. PBMs come up with lists of drugs that receive preferred coverage from insurers and also arrange rebates from drug makers in exchange for favorable insurance coverage.

Sometimes the payments that drug manufacturers make to PBMs are passed on to insurers, and sometimes insurers pass on to patients the savings from those rebates. But the amount of those payments are kept secret.

Sound complicated and opaque? Alexander seems to thinks so too.

 “Why don’t we just get rid of rebates and let you negotiate directly with manufactures, take that $100 billion a year, and just reduce the list price?” Alexander asked Mark Merritt, president and chief executive officer of the Pharmaceutical Care Management Association, which represents pharmacy benefit managers. “Wouldn’t it be simpler for us to understand where the money goes?”

Alexander’s question seemed to betray a misunderstanding of the situation — as he admitted, “I have yet to figure out where [the money] goes” — because pharmacy benefit managers do negotiate directly with manufacturers to determine the rebate amount.

Merritt didn’t say yes or no, but classified rebates as basically “volume discounts,” enabling groups that purchase more drugs to get lower prices.
After the hearing, Merritt clarified to STAT that he would be open to axing rebates.

“We’d be happy if manufacturers would just go to lowering the actual price as opposed to rebating different suppliers and so forth,” Merritt said. “But I don’t see that happening anytime soon.”

Gottlieb's Dueling Acronyms

  • 10.12.2017
  • Peter Pitts
And there are just as many reasons to say "yes" to HHS.


Reports that FDA Commissioner Scott Gottlieb tops President Donald Trump’s list for replacing ousted HHS Secretary Tom Price are reverberating around the Washington echo chamber. The speculation has made its way into so many articles, blogs, tweets and cellphone conversations overheard on the Red Line Metro cars frequented by lobbyists, lawyers and journalists that it has acquired a patina of credibility, even inevitability.

I don’t claim to know whether the job will be offered to Gottlieb or if he would accept it. I do think the interests of patients, FDA, regulated industry and, most likely, Gottlieb himself would be best served if he remains at FDA. Here are four reasons why:


FDA needs stable leadership to produce the regulatory innovation that can turn today’s scientific advances into tomorrow’s medicines.

While the agency can maintain critical functions on autopilot, only a congressionally confirmed leader can break new ground or take controversial steps. Gottlieb has started to take FDA in new directions, for example by making public health arguments for lowering drug prices by tackling pharma company “gamesmanship,” and for making cigarettes less addictive. He has announced plans to release a plan for advancing biomedical innovation that will go beyond the requirements in the recently enacted 21st Century Cures Act and FDA Reauthorization Act.

These projects reflect Gottlieb’s personal experience and vision. It will take years to get them started and on a firm footing. They would likely wither if he departed.


While there certainly are other individuals with the necessary experience and competence to lead FDA, there is no reason to believe they would be nominated if Gottlieb departed.

When Gottlieb was nominated, serious contenders for the position included individuals who want to discard the standards and principles that have made FDA the gold standard for medical product regulation. These guys are still out there, tanned, rested and ready for their opportunity to dismantle the regulatory state and make the world safe for purveyors of snake oil.


Gottlieb lacks the kind of experience required to successfully manage an organization with a trillion-dollar budget and 80,000 employees.

Someone who has been a state governor or headed a state health department or possibly a large university system would be better qualified to deal with the massive budgets, to manage government departments with diverse missions and to placate members of Congress with competing interests.


The person who steps into Price’s shoes will be pinned between a mercurial president prone to humiliating cabinet secretaries, and feuding Republican factions in Congress that are promoting incompatible and impossible healthcare agendas.

The next HHS secretary will be castigated by Republicans for failing to strangle the Affordable Care Act and vilified by Democrats for failing to shore it up. The secretary also will have to defend the Trump administration’s proposals to slash funding for public health and biomedical research. It is difficult to imagine anyone coming out of the job with their integrity and self-respect intact.

If he departs now, Gottlieb will leave no mark behind at FDA, and there aren’t great prospects for advancing the public good at HHS. In contrast, based on his current trajectory, if he stays on the job, Gottlieb is on track to leave with a strong, positive legacy.

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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