Latest Drugwonks' Blog
Two exciting pieces of news from White Oak. The first is that the Director of the National Cancer Institute (NCI), Dr. Ned Sharpless, has been tapped to be the interim Commissioner of the FDA. Whether or not this translates into his getting the official nod for the nomination is anyone’s guess. But he’s clearly the odds on favorite – and that’s a good thing.
The second item of interest is the release of new recommendations for broadening cancer clinical trial eligibility criteria. Per the FDA, these new guidelines will facilitate the design of clinical trials that are more representative of the patient population and maximize the generalizability of the trial results and the ability to understand the therapy's benefit-risk profile across the patient population likely to receive the drug in clinical practice.
This is Big News across a spectrum of issues – including expanded access. As Janet Woodcock mentioned earlier this year, “Expanded access programs are only an iterative step towards more regular and robust use of platform trials.” And, per Bob Temple, “Expanded access protocols can produce data that demonstrate effectiveness in populations outside those studied in registration trials, potentially leading to broader indications.”
Hopefully, Dr. Sharpless will continue to urge divisions – beyond Oncology – to embrace new clinical trial protocols for both orphan diseases and other areas of urgent public health concerns.
The second item of interest is the release of new recommendations for broadening cancer clinical trial eligibility criteria. Per the FDA, these new guidelines will facilitate the design of clinical trials that are more representative of the patient population and maximize the generalizability of the trial results and the ability to understand the therapy's benefit-risk profile across the patient population likely to receive the drug in clinical practice.
This is Big News across a spectrum of issues – including expanded access. As Janet Woodcock mentioned earlier this year, “Expanded access programs are only an iterative step towards more regular and robust use of platform trials.” And, per Bob Temple, “Expanded access protocols can produce data that demonstrate effectiveness in populations outside those studied in registration trials, potentially leading to broader indications.”
Hopefully, Dr. Sharpless will continue to urge divisions – beyond Oncology – to embrace new clinical trial protocols for both orphan diseases and other areas of urgent public health concerns.
Gottliebensraum: Will the FDA need more (or less) living space in a post-Gottlieb world?
Since Scott Gottlieb’s decision to step down as FDA Commissioner the tributes have been coming in fast and furious. And they're all, save for Sid Wolfe of course, well deserved. But here’s something you haven’t thought about – the exceptional role and excellence of the FDA career staff.
One of the reasons that Scott was so successful in so many was because he acknowledged the importance of the FDA's professional staff. Their participation and enthusiasm to share his agenda has helped create a more elastic and angular FDA.
So, now what happens? Can the many initiatives begun at say, CDER, gain and maintain velocity? Or do they kind of just fade away? How sharp will FDA elbows be as we slowly march our way towards another glorious round of PDUFA-Palooza? And e-cigarettes? Will planned agency actions back a half-step back to stay quiet and avoid attention? Or will we get a surprise?
Swap out NCI for FDA? It’s been done before and wasn’t a disaster, but why disrupt two agencies that are functioning well when you don’t have to. Alex Azar has seen this before as well and his suggestions will carry a lot of weight. As will the Vice President’s.
Is the President a wildcard? Are you kidding me? So, there’s that.
Momentum comes from without and within. A Scott-Free FDA presents a lot of opportunity space. (But, then again, I’m a cockeyed optimist.)
Stay tuned.
Since Scott Gottlieb’s decision to step down as FDA Commissioner the tributes have been coming in fast and furious. And they're all, save for Sid Wolfe of course, well deserved. But here’s something you haven’t thought about – the exceptional role and excellence of the FDA career staff.
One of the reasons that Scott was so successful in so many was because he acknowledged the importance of the FDA's professional staff. Their participation and enthusiasm to share his agenda has helped create a more elastic and angular FDA.
So, now what happens? Can the many initiatives begun at say, CDER, gain and maintain velocity? Or do they kind of just fade away? How sharp will FDA elbows be as we slowly march our way towards another glorious round of PDUFA-Palooza? And e-cigarettes? Will planned agency actions back a half-step back to stay quiet and avoid attention? Or will we get a surprise?
Swap out NCI for FDA? It’s been done before and wasn’t a disaster, but why disrupt two agencies that are functioning well when you don’t have to. Alex Azar has seen this before as well and his suggestions will carry a lot of weight. As will the Vice President’s.
Is the President a wildcard? Are you kidding me? So, there’s that.
Momentum comes from without and within. A Scott-Free FDA presents a lot of opportunity space. (But, then again, I’m a cockeyed optimist.)
Stay tuned.
Those of us who have worked with Scott Gottlieb were not surprised at the extraordinary energy and focus he brought to the job as FDA Commissioner. Similarly, it was unsurprising that Scott announced his resignation effective next month. As dedicated as he was to the role at the FDA, he is even more devoted to his family.
His tenure was short but his impact on the agency and the public health will be enduring. Scott spent most of time and energy implementing the 21st Century Cures act and building the infrastructure to move product development away from randomized controlled trials and encouraging the use of predictive biomarkers and real-world evidence. His public pronouncements about drug prices, PBMs and vaping were not mere rhetoric. Though all the initiatives in these areas are not fully implemented, it is to be noted that Scott never said or tweeted anything he was not prepared to back up with action.
Most important, Scott raised the bar for the next FDA commissioner. The agency – and the country – has been blessed with a series of solid FDA commissioners over the past decade or more. Mark McClellan, Andy von Eschenbach, Peggy Hamburg, Rob Califf all made important contributions to the FDA’s modernization and its movement away from what Scott called the hunger for statistical certainty. It can be truly said that the FDA is now leading the way in personalized medicine, regenerative medicine and applying regulatory policy to promote competition.
There are some who still wish to turn the clock back on a decade of FDA reform. Organizations funded by John Arnold, in particular, want to use FDA regulation to slow down drug development, limit investment in orphan drugs and eliminate patient-centered drug development. But Scott has, by showing how smart regulation is done, demonstrated that much would be lost if we turn back now. He built, enlarged and secured a broad consensus about FDA’s mission. In doing so, Scott did something nearly impossible in public policy today: he turned a government agency into a source of health, hope, and possibility.
Well done.
What the best advice for a bevy of Big Pharma execs as they prepare for a Congressional crucifixion? Don’t bend over.
Just the other day, the New York Times ran an editorial titled, “It’s Time for Pharmaceutical Companies to Have Their Tobacco Moment.” Do the CEOs need a roadmap to know where this is going? Medicines save lives. Tobacco kills. While the headline is off-base and objectionable, the prose makes a number of important points that can be summed up in one statement: Pharma has a lot of explaining to do.
So, here’s the good news – it’s a terrific opportunity to speak truth to power. But, will that happen? Here’s what Senator Charles Grassley had to say on the matter:
“I hope that the drug CEOs testifying tomorrow don’t try to blame everyone but themselves/take no responsibility for their role in fixing the problem. We already understand there are other factors to consider. Tomorrow is about the part drug companies can do to lower costs for patients and taxpayers.”
Wise words from a wise man. But will those posing the questions be seeking sage advice or their very own "I am Torquemada" moment?
It’s time we all took to heart the Japanese proverb, “Don’t fix the blame. Fix the problem.”
And to those CEOs preparing their remarks – be honest, forceful and helpful. Call it as you see it. Have solutions. That’s why you earn the big bucks.
As the great Frank Douglas reminds us, "It's not what you control, it's what you contribute."
Do the right thing.
Just the other day, the New York Times ran an editorial titled, “It’s Time for Pharmaceutical Companies to Have Their Tobacco Moment.” Do the CEOs need a roadmap to know where this is going? Medicines save lives. Tobacco kills. While the headline is off-base and objectionable, the prose makes a number of important points that can be summed up in one statement: Pharma has a lot of explaining to do.
So, here’s the good news – it’s a terrific opportunity to speak truth to power. But, will that happen? Here’s what Senator Charles Grassley had to say on the matter:
“I hope that the drug CEOs testifying tomorrow don’t try to blame everyone but themselves/take no responsibility for their role in fixing the problem. We already understand there are other factors to consider. Tomorrow is about the part drug companies can do to lower costs for patients and taxpayers.”
Wise words from a wise man. But will those posing the questions be seeking sage advice or their very own "I am Torquemada" moment?
It’s time we all took to heart the Japanese proverb, “Don’t fix the blame. Fix the problem.”
And to those CEOs preparing their remarks – be honest, forceful and helpful. Call it as you see it. Have solutions. That’s why you earn the big bucks.
As the great Frank Douglas reminds us, "It's not what you control, it's what you contribute."
Do the right thing.
How bad is it getting for Purdue Pharma? Bad enough that they're actually fighting back – and not pulling any punches.
They’ve responded forcefully to the recent 60 Minutes episode with a tick-tock response and a very unambiguous lawyers letter.
Some snippets:
Contrary to assertions that FDA’s changes to the OxyContin indication in 2001 broadened the medicine’s use to chronic pain, the opposite was actually the case. In July 2001, to address extensive abuse of OxyContin, FDA added a black box warning and narrowed the indication to “the management of moderate to severe pain when a continuous, around the clock analgesic is needed for an extended period of time.”
Purdue Pharma expressed concerns in the following letter to Mr. Bill Owens, Executive Producer of 60 Minutes …
Despite multiple meetings, phone calls, and email exchanges between representatives of Purdue and 60 Minutes Associate Producer Sam Hornblower (during which detailed information was exchanged), we are still concerned that Mr. Hornblower and 60 Minutes intend to air a biased and one-sided segment rife with significant errors and inaccuracies, and that 60 Minutes will refuse to disclose to its viewers critical information about the sources it intends to rely on (and even put on the air), including their personal biases toward Purdue and their financial incentives in making false and misleading statements about the company and OxyContin.
Dr. Kolodny has admitted, in the form of a court-filed expert disclosure report made under the penalty of perjury, to the fact that he is a paid consultant and advisor, earning $725/hour for his services.2He also lists on his CV that he submitted to the U.S. House of Representatives Committee on Energy and Commerce on February 27, 2018 as part of his required disclosures prior to his testimony under oath, that he served in a “CONSULTING AND ADVISING” role for “CBS 60 Minutes” in 2017 as part of 60 Minutes’ “The Whistleblower” segment. A copy of this expert disclosure report and Dr. Kolodny’s CV he submitted for his congressional testimony is enclosed for your reference. The facts demonstrate that Dr. Kolodny admits that he worked for 60 Minutes as a consultant and advisor within the last two years (and on a segment that touched on substantially similar subject matter is this segment) and that he is also a paid consultant on behalf of plaintiffs currently involved in active litigation with Purdue.
In that same vein and upon information and belief, we understand that Dr. Kessler has also performed extensive work for and has long consulted with and on behalf of plaintiff-side law firms who are or have been engaged in litigation against Purdue regarding the very same issues he purports 6to comment on for 60 Minutes’ planned segment. These types of consulting and advising roles for law firms involved in active or potential litigation are rarely if ever performed for free. It is incumbent upon 60 Minutes, as the ultimate publisher and airer of segments featuring biased and conflicted individuals like Dr. Kolodny and Dr. Kessler, to thoroughly investigate and vet its own sources and intended on-screen interviewees to confirm any such biases and financial incentives for promoting certain viewpoints and commentary. And where such biases and financial or otherwise personal motives to provide one-sided, incomplete, and even false commentary on a subject matter such as opioid use in the United States exists(as it clearly does with Dr. Kolodny and Dr. Kessler who are, at a minimum, paid-for consultants by individuals and parties who are currently suing Purdue), 60 Minutes has a duty to its viewers to clearly and unambiguously disclose such bias and the facts supporting their incentive and motivation for their viewpoints and commentary during any aired segment in which Dr. Kolodny and Dr. Kessler participate in, and to confront such bias head-on.
Transparency for thee but not for me?
Powerful stuff.
As Pharma CEOs prepare to step up to the plate and face a Congressional grilling, it’s time for Pharma to forcefully defend itself with context and … the truth.
They’ve responded forcefully to the recent 60 Minutes episode with a tick-tock response and a very unambiguous lawyers letter.
Some snippets:
Contrary to assertions that FDA’s changes to the OxyContin indication in 2001 broadened the medicine’s use to chronic pain, the opposite was actually the case. In July 2001, to address extensive abuse of OxyContin, FDA added a black box warning and narrowed the indication to “the management of moderate to severe pain when a continuous, around the clock analgesic is needed for an extended period of time.”
Purdue Pharma expressed concerns in the following letter to Mr. Bill Owens, Executive Producer of 60 Minutes …
Despite multiple meetings, phone calls, and email exchanges between representatives of Purdue and 60 Minutes Associate Producer Sam Hornblower (during which detailed information was exchanged), we are still concerned that Mr. Hornblower and 60 Minutes intend to air a biased and one-sided segment rife with significant errors and inaccuracies, and that 60 Minutes will refuse to disclose to its viewers critical information about the sources it intends to rely on (and even put on the air), including their personal biases toward Purdue and their financial incentives in making false and misleading statements about the company and OxyContin.
Dr. Kolodny has admitted, in the form of a court-filed expert disclosure report made under the penalty of perjury, to the fact that he is a paid consultant and advisor, earning $725/hour for his services.2He also lists on his CV that he submitted to the U.S. House of Representatives Committee on Energy and Commerce on February 27, 2018 as part of his required disclosures prior to his testimony under oath, that he served in a “CONSULTING AND ADVISING” role for “CBS 60 Minutes” in 2017 as part of 60 Minutes’ “The Whistleblower” segment. A copy of this expert disclosure report and Dr. Kolodny’s CV he submitted for his congressional testimony is enclosed for your reference. The facts demonstrate that Dr. Kolodny admits that he worked for 60 Minutes as a consultant and advisor within the last two years (and on a segment that touched on substantially similar subject matter is this segment) and that he is also a paid consultant on behalf of plaintiffs currently involved in active litigation with Purdue.
In that same vein and upon information and belief, we understand that Dr. Kessler has also performed extensive work for and has long consulted with and on behalf of plaintiff-side law firms who are or have been engaged in litigation against Purdue regarding the very same issues he purports 6to comment on for 60 Minutes’ planned segment. These types of consulting and advising roles for law firms involved in active or potential litigation are rarely if ever performed for free. It is incumbent upon 60 Minutes, as the ultimate publisher and airer of segments featuring biased and conflicted individuals like Dr. Kolodny and Dr. Kessler, to thoroughly investigate and vet its own sources and intended on-screen interviewees to confirm any such biases and financial incentives for promoting certain viewpoints and commentary. And where such biases and financial or otherwise personal motives to provide one-sided, incomplete, and even false commentary on a subject matter such as opioid use in the United States exists(as it clearly does with Dr. Kolodny and Dr. Kessler who are, at a minimum, paid-for consultants by individuals and parties who are currently suing Purdue), 60 Minutes has a duty to its viewers to clearly and unambiguously disclose such bias and the facts supporting their incentive and motivation for their viewpoints and commentary during any aired segment in which Dr. Kolodny and Dr. Kessler participate in, and to confront such bias head-on.
Transparency for thee but not for me?
Powerful stuff.
As Pharma CEOs prepare to step up to the plate and face a Congressional grilling, it’s time for Pharma to forcefully defend itself with context and … the truth.
Per the New York Times editorial, “How Much Will Americans Sacrifice for Good Health Care?, one urgent issue relative to a broader government role in providing healthcare is rationing. No nation (and certainly not those in Europe or Canada) provide universal access to everything. Government bureaucrats make decisions about what medical treatments (new cancer drugs, surgeries, new genetic interventions, etc.) are paid for.
Today, of the 74 cancer drugs launched between 2011 and 2018, 95% are available in the United States, 74% in the U.K., 49% in Japan, and 8% in Greece. Access to these cutting-edge drugs means that patients can use the latest treatments to help cure their conditions; it’s why the United States has the highest five-year survival rate for cancers in the world.
Do we want Uncle Sam, MD to replace the considered opinions of our own physicians? Government-paid healthcare presents significant hurdles as well as interesting opportunities and healthcare rationing is an important part of the discussion about any kind of government-run healthcare proposal.
Today, of the 74 cancer drugs launched between 2011 and 2018, 95% are available in the United States, 74% in the U.K., 49% in Japan, and 8% in Greece. Access to these cutting-edge drugs means that patients can use the latest treatments to help cure their conditions; it’s why the United States has the highest five-year survival rate for cancers in the world.
Do we want Uncle Sam, MD to replace the considered opinions of our own physicians? Government-paid healthcare presents significant hurdles as well as interesting opportunities and healthcare rationing is an important part of the discussion about any kind of government-run healthcare proposal.
I wrote two op-eds that just happened to be published the same day (today)
The first one explains whyTrump's Prescription Drug Price Reform is Promising.
Soaking the Sick to Make the Rich Even Richer discusses how Democrat opposition to the Trump proposal has led legislators from that party propose giving PBMs more control over access to medicines.
Not many people are told, at gunpoint no less, by a dictator to take the next flight out of his country and never come back. Fewer still have replied by asking the dictator to pay for the trip, let alone live to do so.
But such quiet acts of defiance connect the "Defining Moments of a Free Man From a Black Stream" by Frank Douglas. Douglas, one of the most highly honored and respected leaders in the pharmaceutical industry, could have written an entire book about his many careers ranging from a physician, a drug development executive, venture capital advisor, biotech CEO and director of two initiatives to accelerate the commercialization of academic life science research and that alone would have been interesting, informative and inspiring. But the formative experiences, the events that truly defined the life of Frank Douglas, were forged not in corporate boardrooms or high-level meetings but instead in how he chose to act when faced with beatings, homelessness, outright racism, and political intimidation.
The autobiography opens with a 12 year Frank Douglas being whipped by his mother after being told that he deliberately dumped a week's worth of groceries from his bicycle basket by her emotionally unstable and sadistic sister, Edith. It wasn't the first time. Edith took a sick delight in blaming Frank for things he did not do, knowing that it would lead to a beating. After this incident, Frank decided he had no choice but to kill himself by plunging into the deep waters off the coast of his native Guyana.
He asked himself how much "hope is there for a boy of twelve when in his own home he cannot defend himself or defend against injustice?" Ever the rational being, Frank realized that the possibility of jumping and living in pain wasn't worth the effort to commit suicide. Instead, he "concluded that there had to be a different solution to my dilemma."
He ran to the home of a woman he called "Moms" who is the mother would take to visit every Sunday after church and declared he wanted to live there. It was then that Moms told Frank that her son was his real father. The revelation did not devastate him, it made him stronger. He went home, no longer a victim, and told his mother and aunt Edith he would not be beaten or manipulated again.
Such defiance was forged from faith and fearlessness in confronting events and forces that appeared to be beyond his control. Much like Jacob wrestled God from darkness into dawn before receiving the name Israel, Frank Douglas truly earned his name (which literally means a free man from a black stream) by virtue of his willingness to confront malevolent, even violent forces throughout his life.
Throughout his academic career which took him from a small private school in Guyana to Lehigh University and then to Cornell for a Ph.D. in Chemistry and a medical degree, Douglas faced outright racism. Others would have endured it or, especially today sought to triumph by being defined as a victim. Instead, Frank Douglas took on the threats, often without regard to short term consequences, by confronting those who wanted to squash him because he was black.
If he had acted otherwise, the world would be a lesser place. His novel approaches to conducting drug discovery and development spread from the companies he worked for and transformed practice throughout the industry. The hundreds of students and entrepreneurs that sustain medical innovation would be fewer in number and less effective. And those fortunate enough to have read the book would not have the privilege of being taught an ageless lesson about the human condition: that our character is not just our destiny, it is the legacy we leave behind. And as Defining Moments demonstrates, that heritage is shaped by the work of our own hearts and hands and not the faceless, inexorable traverse from past to future.
But such quiet acts of defiance connect the "Defining Moments of a Free Man From a Black Stream" by Frank Douglas. Douglas, one of the most highly honored and respected leaders in the pharmaceutical industry, could have written an entire book about his many careers ranging from a physician, a drug development executive, venture capital advisor, biotech CEO and director of two initiatives to accelerate the commercialization of academic life science research and that alone would have been interesting, informative and inspiring. But the formative experiences, the events that truly defined the life of Frank Douglas, were forged not in corporate boardrooms or high-level meetings but instead in how he chose to act when faced with beatings, homelessness, outright racism, and political intimidation.
The autobiography opens with a 12 year Frank Douglas being whipped by his mother after being told that he deliberately dumped a week's worth of groceries from his bicycle basket by her emotionally unstable and sadistic sister, Edith. It wasn't the first time. Edith took a sick delight in blaming Frank for things he did not do, knowing that it would lead to a beating. After this incident, Frank decided he had no choice but to kill himself by plunging into the deep waters off the coast of his native Guyana.
He asked himself how much "hope is there for a boy of twelve when in his own home he cannot defend himself or defend against injustice?" Ever the rational being, Frank realized that the possibility of jumping and living in pain wasn't worth the effort to commit suicide. Instead, he "concluded that there had to be a different solution to my dilemma."
He ran to the home of a woman he called "Moms" who is the mother would take to visit every Sunday after church and declared he wanted to live there. It was then that Moms told Frank that her son was his real father. The revelation did not devastate him, it made him stronger. He went home, no longer a victim, and told his mother and aunt Edith he would not be beaten or manipulated again.
Such defiance was forged from faith and fearlessness in confronting events and forces that appeared to be beyond his control. Much like Jacob wrestled God from darkness into dawn before receiving the name Israel, Frank Douglas truly earned his name (which literally means a free man from a black stream) by virtue of his willingness to confront malevolent, even violent forces throughout his life.
Throughout his academic career which took him from a small private school in Guyana to Lehigh University and then to Cornell for a Ph.D. in Chemistry and a medical degree, Douglas faced outright racism. Others would have endured it or, especially today sought to triumph by being defined as a victim. Instead, Frank Douglas took on the threats, often without regard to short term consequences, by confronting those who wanted to squash him because he was black.
If he had acted otherwise, the world would be a lesser place. His novel approaches to conducting drug discovery and development spread from the companies he worked for and transformed practice throughout the industry. The hundreds of students and entrepreneurs that sustain medical innovation would be fewer in number and less effective. And those fortunate enough to have read the book would not have the privilege of being taught an ageless lesson about the human condition: that our character is not just our destiny, it is the legacy we leave behind. And as Defining Moments demonstrates, that heritage is shaped by the work of our own hearts and hands and not the faceless, inexorable traverse from past to future.
Very important initiative from the FDA to update DSHEA – without even once mentioning CBD oil. If you don't think the agency takes the twin issues of quality and claims seriously -- think again. Some excerpts:
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight
The opportunity to strengthen the framework that governs dietary supplements couldn’t come at a more pivotal time. On the one hand, advances in science and the growth and development in the dietary supplement industry carries with it many new opportunities for consumers to improve their health. At the same time, the growth in the number of adulterated and misbranded products – including those spiked with drug ingredients not declared on their labels, misleading claims, and other risks – creates new potential dangers.
Legitimate industry benefits from a framework that inspires the confidence of consumers and providers. Patients benefit from products that meet high standards for quality.
Dietary supplements can, when substantiated, claim a number of potential benefits to consumer health, but they cannot claim to prevent, treat or cure diseases like Alzheimer’s. Such claims can harm patients by discouraging them from seeking FDA-approved medical products that have been demonstrated to be safe and effective for these medical conditions. In recent years, we’ve also taken action against companies and dietary supplements making similar claims regarding treatment of serious conditions such as cancer and opioid addiction. These enforcement actions are just one part of our overall efforts to update our policy framework governing dietary supplements.
Our first priority for dietary supplements is ensuring safety. Above all else, the FDA’s duty is to protect consumers from harmful products. Our second priority is maintaining product integrity: we want to ensure that dietary supplements contain the ingredients that they’re labeled to contain, and nothing else, and that those products are consistently manufactured according to quality standards. Our third priority is informed decision-making. We want to foster an environment where consumers and health care professionals are able to make informed decisions before recommending, purchasing or using dietary supplements.
I’m pleased to announce that we’ve recently created the Botanical Safety Consortium, a public-private partnership that will gather leading scientific minds from industry, academia and government to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements. This group will look at novel ways to use cutting-edge toxicology tools, including alternatives to animal testing, to promote the goals of safety and effectiveness we share with consumers and other stakeholders
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight
The opportunity to strengthen the framework that governs dietary supplements couldn’t come at a more pivotal time. On the one hand, advances in science and the growth and development in the dietary supplement industry carries with it many new opportunities for consumers to improve their health. At the same time, the growth in the number of adulterated and misbranded products – including those spiked with drug ingredients not declared on their labels, misleading claims, and other risks – creates new potential dangers.
Legitimate industry benefits from a framework that inspires the confidence of consumers and providers. Patients benefit from products that meet high standards for quality.
Dietary supplements can, when substantiated, claim a number of potential benefits to consumer health, but they cannot claim to prevent, treat or cure diseases like Alzheimer’s. Such claims can harm patients by discouraging them from seeking FDA-approved medical products that have been demonstrated to be safe and effective for these medical conditions. In recent years, we’ve also taken action against companies and dietary supplements making similar claims regarding treatment of serious conditions such as cancer and opioid addiction. These enforcement actions are just one part of our overall efforts to update our policy framework governing dietary supplements.
Our first priority for dietary supplements is ensuring safety. Above all else, the FDA’s duty is to protect consumers from harmful products. Our second priority is maintaining product integrity: we want to ensure that dietary supplements contain the ingredients that they’re labeled to contain, and nothing else, and that those products are consistently manufactured according to quality standards. Our third priority is informed decision-making. We want to foster an environment where consumers and health care professionals are able to make informed decisions before recommending, purchasing or using dietary supplements.
I’m pleased to announce that we’ve recently created the Botanical Safety Consortium, a public-private partnership that will gather leading scientific minds from industry, academia and government to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements. This group will look at novel ways to use cutting-edge toxicology tools, including alternatives to animal testing, to promote the goals of safety and effectiveness we share with consumers and other stakeholders
When members of the tort bar start to salivate over a piece of legislation, it’s worthwhile to find out where the red meat resides.
In a rush to pass legislation to “lower drug prices,” lawmakers are pushing forward H.R. 965 (Cicilline and Sensenbrenner) and S.340 (Leahy). The worthwhile goal of this new version of the CREATES Act is to prohibit pharmaceutical and biologic companies from engaging in anti-competitive conduct that blocks lower-cost generic drugs from entering the market.
Both bills address an important problem – but create an even bigger one.
This proposed legislation establishes a private right of action for “eligible product developers” to sue “license holders” for failure to comply with the process set forth in CREATES for providing access to covered product. Good! But …
As written, the CREATES Act is ripe for abuse by entities that have no intent to actually develop a generic or biosimilar version of the covered product. This potential for abuse is exacerbated by the significant monetary damages available under CREATES—up to the amount of revenue generated on the covered product during the period of violation. Indeed, in certain instances it may be more profitable to litigate and obtain damages under CREATES than it would be to actually market a generic/biosimilar product.
Can you hear the tort bar drooling? Can you hear the tort bar … drafting?
As currently drafted, the CREATES Act could have significant unintended consequences:
The damage provisions of the current draft create the potential for windfall damages, which will distort incentives. Specifically, the bill allows for damages up to the entire gross profit of the brand medicine during the period of negotiations. This creates a powerful incentive for generic companies to prolong negotiations (increasing their damage award), which will actually delay generic entry and competition in the marketplace.
Indeed, generic developers would be able to earn more from a lawsuit than from actually selling the proposed generic drug. An "opportunistic" company (Can you say "Shkreli?") could develop a business model of demanding samples and engaging in litigation for damages without ever submitting an abbreviated application to FDA—undermining the bill’s stated goal to speed availability of lower-cost drugs for patients.
Smart changes will fix these problems, save the government money and achieve the desired policy goals of facilitating generic access to samples and increasing competition; maintaining safeguards for products subject to a REMS; and ensuring generic developers actually develop generic products.
Here’s a savvy path forward:
Establish an affirmative defense for license holders where the license holder has made a timely offer to provide sufficient quantities of samples at commercially reasonable, market-based terms.
Such an affirmative defense is intended to prevent frivolous litigation—where samples are offered on commercially reasonable terms, the eligible product developer should not be able to decline the offer and continue litigation. The term “commercially reasonable, market-based terms” is defined to provide further clarity to all parties and avoid unnecessary litigation. Remedies would not be available if the license holder has established an affirmative defense by a “preponderance of the evidence.”This affirmative defense also protects good acting companies from protracted litigation and stops generic sponsors from unnecessarily prolonging negotiations to increase damages.
Revision to the definition of “eligible product developer” to clarify that the eligible product developer must be a person that seeks to develop “and submit” an application for a generic or biosimilar product.
These change will help ensure that only legitimate manufacturers are considered eligible product developers for purposes of CREATES; entities that seek only to engage in frivolous litigation and do not seek to submit a generic/biosimilar product application would not be eligible for the remedies under CREATES. The tort bar won’t like it – but this important legislation must be about lowering drug prices – not raising their income.
In a rush to pass legislation to “lower drug prices,” lawmakers are pushing forward H.R. 965 (Cicilline and Sensenbrenner) and S.340 (Leahy). The worthwhile goal of this new version of the CREATES Act is to prohibit pharmaceutical and biologic companies from engaging in anti-competitive conduct that blocks lower-cost generic drugs from entering the market.
Both bills address an important problem – but create an even bigger one.
This proposed legislation establishes a private right of action for “eligible product developers” to sue “license holders” for failure to comply with the process set forth in CREATES for providing access to covered product. Good! But …
As written, the CREATES Act is ripe for abuse by entities that have no intent to actually develop a generic or biosimilar version of the covered product. This potential for abuse is exacerbated by the significant monetary damages available under CREATES—up to the amount of revenue generated on the covered product during the period of violation. Indeed, in certain instances it may be more profitable to litigate and obtain damages under CREATES than it would be to actually market a generic/biosimilar product.
Can you hear the tort bar drooling? Can you hear the tort bar … drafting?
As currently drafted, the CREATES Act could have significant unintended consequences:
The damage provisions of the current draft create the potential for windfall damages, which will distort incentives. Specifically, the bill allows for damages up to the entire gross profit of the brand medicine during the period of negotiations. This creates a powerful incentive for generic companies to prolong negotiations (increasing their damage award), which will actually delay generic entry and competition in the marketplace.
Indeed, generic developers would be able to earn more from a lawsuit than from actually selling the proposed generic drug. An "opportunistic" company (Can you say "Shkreli?") could develop a business model of demanding samples and engaging in litigation for damages without ever submitting an abbreviated application to FDA—undermining the bill’s stated goal to speed availability of lower-cost drugs for patients.
Smart changes will fix these problems, save the government money and achieve the desired policy goals of facilitating generic access to samples and increasing competition; maintaining safeguards for products subject to a REMS; and ensuring generic developers actually develop generic products.
Here’s a savvy path forward:
Establish an affirmative defense for license holders where the license holder has made a timely offer to provide sufficient quantities of samples at commercially reasonable, market-based terms.
Such an affirmative defense is intended to prevent frivolous litigation—where samples are offered on commercially reasonable terms, the eligible product developer should not be able to decline the offer and continue litigation. The term “commercially reasonable, market-based terms” is defined to provide further clarity to all parties and avoid unnecessary litigation. Remedies would not be available if the license holder has established an affirmative defense by a “preponderance of the evidence.”This affirmative defense also protects good acting companies from protracted litigation and stops generic sponsors from unnecessarily prolonging negotiations to increase damages.
Revision to the definition of “eligible product developer” to clarify that the eligible product developer must be a person that seeks to develop “and submit” an application for a generic or biosimilar product.
These change will help ensure that only legitimate manufacturers are considered eligible product developers for purposes of CREATES; entities that seek only to engage in frivolous litigation and do not seek to submit a generic/biosimilar product application would not be eligible for the remedies under CREATES. The tort bar won’t like it – but this important legislation must be about lowering drug prices – not raising their income.
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.
