Latest Drugwonks' Blog

The House is expected to vote on The Improving Regulatory Transparency for New Medical Therapies Act (H.R. 4299). (It has already been approved by the Energy & Commerce Committee.) Companion legislation is expected to be introduced in the Senate soon. The legislation would strengthen the Controlled Substances Act by requiring the DEA to “schedule” medicines 45 days after it receives the FDA’s scheduling recommendation for a new drug.

(The average time between FDA approval and DEA’s final scheduling is about eight months -- and it sometimes takes more than a year.)

The issue at hand is that patients have not been able to access a growing number of new treatments because of a lack of predictable schedule review times – and particularly long evaluation times associated with DEA scheduling decisions.

It’s time for that to change.

The California Assembly just passed (by a vote of 72-0) AB2418, legislation for medication synchronization that “promotes policies designed to improve patient medication adherence.” An earlier draft of the bill included measures that would have given about one million Californians whose health plans require them to order prescriptions through the mail an option to waive that requirement -- but some strong business interests threw a fit. Fortunately, the bill does specifically addresses pharmacy synchronization, a tried and true methodology for significantly improving medication compliance. It now heads to the Governor’s desk.

It should be a no-brainer for Governor Brown -- but the Assembly’s unanimity isn’t as complete as the vote makes it look.

The mail order measure was strongly supported bya wide swath of patient groups, seniors’ organizations, provider associations, labor unions, pharmacies, and business support. Alas, it was killed by the profits over patients crowd consisting of Aetna, American’s Health Insurance Plans, Association of California Life and Health Insurance Companies, Blue Shield of California, California Association of Health Plans, Express Scripts, and the Pharmaceutical Care Management Association.

Their rationale: mail order is cheaper – at least in the short-term. The Pharmaceutical Care Management Association has launched a campaign against the bill that includes the release of a study finding that mail-order pharmacies save about 16% more than brick-and-mortar pharmacies, including $500 million in savings next year on regular prescription medications. However, the study also noted that stand-alone prescription drugs often were more costly through mail-order pharmacies.

According to the U.S. Centers for Medicare and Medicaid Services (CMS), the estimated cost of synchronization to Part D sponsors is meager $0.5million, while the savings to Part D sponsors and beneficiaries is $1.8 billion. And there will be an overwhelming reduction in overall health care costs because of improved patient outcomes due to enhanced medication adherence, which should lead to higher quality ratings for a health insurance plan.

The Assembly vote notwithstanding, Governor Brown’s signature on the bill isn’t assured. And the lobbying is intense.
The health plans and PBMs mentioned above are still strongly opposed and actively lobbying for a veto

Governor Brown’s signature to AB 2418 will result in better health and lower costs.

The New York Times reports that, The City of Chicago and two California counties are challenging the drug industry’s way of doing business, contending in two separate lawsuits that “aggressive marketing” by five companies has fueled an epidemic of addiction and cost taxpayers millions of dollars in insurance claims and other health care costs.

Do they know more than OPDP? Have they contacted the FDA? Do they have legal standing or is this a case of Federal Preemption? None of these questions are addressed in the article.

Also left unmentioned is that Purdue Pharma (mentioned at great length in the Times article as a defendant), is working with the U.S. Attorney's Office, Central District of California to help convict felonious pharmacists who operated an opioid diversion ring.

As Aldous Huxley famously said, “Facts do not cease to exist because they are ignored.”

Joshua Lederberg, the Nobel Prize Laureate once observed that the failure of regulatory, legal and political institutions to integrate scientific advances into risk selection and assessment was the most important barrier to improved public health.  

Lederberg noted that in the absence of such changes,  "the precedents affecting the long-term rationale of social policy will be set, not on the basis of well-debated principles, but on the accidents of the first advertised examples."

Policies and regulations that seek to limit risk are often shaped by the immediate fear of sensational events. This perspective is commonly called "The Precautionary Principle" which in various forms asserts that unless innovators can demonstrate that a new technology is risk free, it should be not allowed into the marketplace.  Moreover, any product that could possibly be dangerous at any level should be strictly and severely regulated. 

Which brings us to yesterday’s announcement that the federal government (led by the DEA) is finalizing new restrictions on hundreds of medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S.

The new rules mean that drugs like Vicodin, Lortab and other generic versions will be subject to the same prescribing rules as painkillers like codeine and oxycodone. Patients will be limited to one 90-day supply of medication and will have to see a health care professional to get a refill. Additionally, in many states prescribing authority will be limited to physicians, not nurses or physician assistants.

Will this limit abuse? That’s a theory. What's a fact is the negative impact it will have on the tens of millions of Americans who suffer from chronic pain.

Last September, CMPI held a conference on the issue of opioid pain medications. One of the panelists was Cindy Steinberg, the National Director of Policy and Advocacy for the US Pain Foundation. Here’s what she had to say about upscheduling:

That’s going to mean that people need to see their doctor at least four and sometimes 12 times a year just to obtain a script because of the very strict requirements on Schedule II medications. The hydrocodone combinations are now Schedule III and if they are upscheduled, in Massachusetts for example, where Schedule II scripts expire in 30 days and cannot be written for more than a 30 day supply, many people in my group are that are taking hydrocodone combinations medications would have to see their doctor every 30 days for a script.

They now see their doctor perhaps twice a year. So, they would have to go see their doctor 12 times per year. People have a hard time finding a pain doctor period, let alone getting an appointment.

Somebody in my group was referred to a pain specialist in January of 2012 and the first appointment she was able to get was in December of 2012. She had to wait almost an entire year to see a pain doctor. So how are we going to handle the number of people that are going to need appointments to get their medications? In Massachusetts, as I mentioned Schedule II scripts expire in 30 days and by federal law cannot be refilled. I have a person in my group that has osteonecrosis. He was an early heart transplant patient and the steroids he had to take to maintain his organ transplant resulted in osteonecrosis which has eroded every joint in his body. He’s had multiple joint replacements and lives with a very high degree of pain. His wife has to drive him to the doctor now every 30 days in order to get his Schedule II medication because he needs to get a physical script. And that’s going to happen to many people if these Schedule III medications are rescheduled. And as I mentioned, given all those extra appointments, think about what that is going to do to healthcare costs.

Upscheduling will result in tighter restrictions for patients who really need the medications, more paperwork for physicians and a heavier workload for pharmacists. Abusers and criminals rarely follow regulations.

This past June, the FDA launched openFDA, a new initiative designed to make it easier for web developers, researchers and the public to access large, important public health datasets collected by the agency.

According to the agency, the initiative is the result of extensive research with internal officials and external developers to identify those datasets that are in recurrent demand and are traditionally fairly difficult to use. Based on this research, the FDA decided to phase in openFDA beginning with an initial pilot program involving the millions of reports of drug adverse events and medication errors that have been submitted to the FDA from 2004 to 2013. Previously, the data was only available through difficult to use reports or Freedom of Information Act requests.

And this week the FDA unveiled a new Application Programming Interface that offers data from the agency’s database containing medical-device adverse event reports, going back to 1992.

The crowd-sourcing of adverse event data may or may not yield interesting results, but it’s a good place to start. It represents an opportunity for the agency to begin designing a more evolved approach to 21st century pharmacovigilance.

For the rest of the story see OpenFDA: The Key To Moving Pharmacovigilance Into the 21st Century in the new edition of PM360.

Referring to the Model T, Henry Ford famously said, "Any customer can have a car painted any color that he wants so long as it is black.” That worked out fine – until there was competition. Choice is the great emancipator. The same is true when it comes to healthcare – and a lot more important.

When it comes to the Affordable Care Act, patients can access any medicine they need -- as long as it's on the exchange formulary. Sure, the ACA limits the degree to which insurers can charge higher premiums for sicker patients, but ObamaCare plans found a way around these rules: impose higher out-of-pocket costs for all or most specialty drugs. High co-pays effectively remove choice from the system for many patients.

The breakdown of Silver plans (the most popular category) is particularly revealing. In seven classes of drugs for conditions from cancer to bipolar disorder, more than a fifth of these plans require patients to shoulder 40 percent of the medicine’s cost. And 60 percent of Silver plans place all drugs for illnesses like multiple sclerosis and rheumatoid arthritis in the “formulary tier” with the highest level of cost-sharing.

Nearly every Silver plan across the country, in fact, puts at least one class of drug exclusively in the top cost-sharing tier. In effect, this leaves patients with a given condition — whether HIV or Crohn’s disease — without a single affordable treatment option. Silver is the new Black.

And those signing up for Silver plans don’t know what’s going to hit them until they access the healthcare system. It’s time, at least, for that to change. It’s time for exchange transparency.

The American Legislative Exchange Council (a forum for state legislators and private sector members to collaborate on model legislation that members can customize and introduce for debate in their own state legislatures) has drafted the “Exchange Transparency Act.” Whatever your position on ObamaCare (or, if you prefer, the Affordable Care Act), it makes a lot of sense. If there’s nothing to hide then there shouldn’t be a problem.

Exchange Transparency Act


Requires health plans offered through a state-based health exchange to provide specific information in order for consumers to draw meaningful comparisons between plans.

Model Policy

Section 1. Title. This Act shall be known as the “Exchange Transparency Act.”

Section 2. Form of Information Available to the Public and Disclosures Required of Health

Insurers. The following information about each health plan offered for sale to consumers shall be available to consumers on {insert state-based exchange website} in a clear and understandable form for use in comparing plans, plan coverage, and plan premiums:

 (1) The ability to determine whether specific types of specialists are in network and to determine whether a named physician, hospital or other health care provider is in network;

 (2) Any exclusions from coverage and any restrictions on use or quantity of covered items and services in each category of benefits;

 (3) A description of how medications will specifically be included in or excluded from the deductible, including a description of out-of-pocket costs that may not apply to the deductible for a medication;

 (4) The specific dollar amount of any copay or percentage coinsurance for each item or service;

 (5) The ability to determine whether a specific drug is available on formulary, the applicable cost-sharing requirement, whether a specific drug is covered when furnished by a physician or clinic, and any clinical prerequisites or authorization requirements for coverage of a drug;

(6) The process for a patient to obtain reversal of a health plan decision where an item or service prescribed or ordered by the treating physician has been denied; and

(7) An explanation of the amount of coverage for out of network providers or non-covered services, and any rights of appeal that exist when out of network providers or non-covered services are medically necessary.

Section 3. Enforcement. The {insert state insurance commissioner} may impose fines on any entity failing to meet the requirements of this act.

What’s the ETA of the ETA? Stay tuned.

Leaders Lead

  • 08.18.2014

FDA Should Lead Ongoing Opioid Debates, Former Agency Official Says

FDA Week                                                                                                                                         
By Stephanie Beasley 

Former FDA Associate Commissioner for External Relations Peter Pitts said the agency has been too quiet in escalating debates about opioid regulation and has missed recent opportunities to explain the science behind its decisions. FDA should be the lead voice on the issue of abuse deterrence and safe use of opioids but instead the conversation has been dominated by state and federal lawmakers, lawyers and advocacy groups, said Pitts, now president of the Center for Medicine in the Public Interest.

In "Who 'Lost' Opioids?" -- an article that appears in the July issue of the Journal of Commercial Biotechnology -- Pitts said FDA is losing the "struggle" to control the national conversation about opioid abuse. He said lawmakers, state attorneys general, medical groups and others have pushed FDA to reverse it's recent approval of pure hydrocodone Zohydro and for the agency to require all opioids be abuse deterrent. But the agency's scientific basis for not taking those actions has been overlooked, he said.

He notes that during testimony in the Senate earlier this year, FDA Commissioner Margaret Hamburg indicated that the agency would be reluctant to require all opioids use abuse-deterrent formulations until there is more evidence to prove they actually deter abuse. Further, he notes that while many critics of FDA's Zohydro approval have correctly cited the fact that the decision was made against the recommendation of an advisory committee, they failed to mention that the experts also affirmed there was no evidence suggesting Zohydro had greater abuse or addiction potential than other opioids.

FDA needs to bring more attention to these factors and talk about what it is doing to progress abuse deterrent opioid development, he said. "The FDA needs to continue to speak out regularly on what it is doing to help further the initiatives that it has put in place," Pitts told FDA Week. "The FDA has many, many important issues to address and opioids is only one of them, but this doesn't excuse either inaction or lack of communications. Leaders lead."

He said, for example, FDA could have spoken about progress made on abuse deterrence when it approved Purdue Pharma's abuse-deterrent oxycodone last month (see FDA Week, July 24). That was a missed opportunity to talk about the significance that kind of drug might have on the development of abuse-deterrent formulations, Pitts said. He added that FDA has also been meeting with opioid manufacturers to address issues related to abuse deterrence but has provided no information about what solutions have been proposed or when they might be implemented.

In September, FDA updated the Risk Evaluation and Mitigation Strategy for extended-release opioids to require a statement that the products were appropriate for pain severe enough to require daily and continual long-term treatment, among other changes. The agency also issued guidance on abuse deterrence last year, but has yet to release a separate guidance for abuse-deterrent generics, although agency officials have said they do not plan to require generics use the same technology as innovators.

Pitts was also critical of lawmakers that have pressed the agency to reverse its Zohydro approval. Democratic Sens. Joe Manchin (WV) and Charles Schumer (NY) have been active on the issue. Manchin introduced a bill that would reverse the approval while Schumer has urged HHS to overturn the decision. Twenty-eight state attorneys general have also called for FDA to reverse its Zohydro approval.

"Whatever your position on the issue of opioids, the proper venue for this decision is not the office of the Secretary of HHS or the halls of Congress or the courts -- but rather the office of the FDA Commissioner," Pitts said.

He also took issue with groups like Consumers Union that are weighing in on the issue but that he said were ignoring the science behind FDA policy. Last month, CU's Consumer Reports released an article warning consumers about the dangers of painkillers and specifically asking FDA to reconsider its Zohydro approval and limit acetaminophen to 325 milligrams per pill. The group further said that while 90 percent of long-term chronic pain sufferers are prescribed opioids, there is little evidence that the drugs are beneficial or safe for long-term use. It is also safer to use short-acting opioids that stay in the body for less time and avoid taking large doses of acetaminophen, according to the article.

Pitts called the article "error filled" and criticized Consumer Reports for misrepresenting the information as fact-based and non-biased. But Lisa Gill, lead editor for the article, said the group stood by its story. It is important to remember that Consumer Reports is coming at the topic from a consumer, not regulatory perspective, she said. Gill added that the report was also released in direct response to Centers for Disease Control and Prevention data identifying opioid misuse and abuse as a public health crisis.

"The story evolved out of the CDC calling opioid abuse a public health crisis," Gill said. "Because it is still an issue we wanted to cover it in a profound way."

She said the point of the article was to address common misconceptions among consumers and help them make healthcare decisions and also noted that Consumer Reports does feel FDA could be doing more to address opioid abuse, like requiring prescriber education for providers prescribing Zohydro.

Pitts also called for more education on opioid dispensing and the development of best practices. Those best practices could be developed by continuing medical education groups and prescription drug monitoring programs, he said.

In an outrageous commentary in the British Medical Journal, Sid Wolfe cites a JAMA study that claims “new black-box warnings and safety withdrawals have increased following PDUFA’s enactment, perhaps as a result of an expedited review process that may not adequately detect serious drug safety problems in the preapproval period.”

Statistics, the saying goes, are like a bikini. What they show you is interesting, but what they conceal is essential. In the case of Dr. Wolfe, it’s a case (in fact, the latest in a series) of taking evidence and selectively using it to prove a long-held theory. In the case of Sid Wolfe, the theory is that PDUFA puts FDA in industry’s pocket. Nothing could be further from the truth.

Much has changed since the introduction of user fees in 1992 and one of the most important changes has been in the medical innovation. Since 1992 both small and large molecules have become more complex. Since 1992 these new medicines have addressed the unmet medical needs of many orphan and serious chronic diseases.

But new drugs are more than about just reward. Many of these new FDA-approved medicines have a higher risk profile. And with better data management tools, the FDA is now able to capture adverse event information in a more timely and accurate manner. This is especially important when it comes to the approval of medicines with a higher risk profile. Post-marketing pharmacovigilance, whether in the form of more targeted REMS or more sophisticated surveillance techniques allows the FDA to pursue expedited approval pathways for those medicines it feels fill a void in the therapeutic armamentarium. The voice of patients supports this approach, as does that or practitioners. And it also supports innovation.

As Paul J. Seligman, former chief of post-marketing drug surveillance at the FDA, commented back in 2005, it’s important to “develop the science for monitoring adverse events in ways that will allow us to give adequate warnings.”

No pharmaceutical company wants its product brought to market more swiftly if that will lead to a rapid recall. The fact that there are more products with boxed warnings is a direct consequence of the FDA’s efforts to better inform physicians and patients to the risk/reward ratio of these new products. It’s 21st century safe use or, as the French refer to it, bon usage. In that respect, more product withdrawals are the natural consequence of better pharmacoviiglance – the counterweight to expedited approvals of higher risk medicines.

And nothing to do with PDUFA fees.

Fragile Fraternity

  • 08.14.2014

So much for regulatory fraternity …

PhRMA, BIO Open Fire On FDA's Biosimilars Guidance

By Jeff Overley

Law360, New York (August 13, 2014, 7:11 PM ET) -- Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Association are leading an attack by innovator drugmakers on the U.S. Food and Drug Administration’s most recent biosimilars guidance, saying in letters released Wednesday that it could let copycat products be sold without fully demonstrating safety and effectiveness.

In correspondence provided to Law360 following a Tuesday comment deadline, the trade groups each questioned biosimilars policies the FDA proposed in May regarding so-called clinical pharmacology data — relatively early research in small groups of human subjects.

PhRMA, for example, took issue with the FDA’s introduction of four categories of similarity — not similar, similar, highly similar, and highly similar with fingerprint-like similarity — saying that the “hierarchy is beyond the scope of the draft guidance.”

If the FDA insists on preserving the categories within the guidance, it should eliminate “vague and confusing” definitions that make it unclear how regulators will decide which classification to apply, PhRMA wrote.

BIO also voiced concerns with the four categories, specifically questioning the FDA’s statement that a product merely deemed similar — and therefore not comparable enough to qualify as a biosimilar — could be deemed highly similar if additional studies help to erase uncertainties.

That additional testing could “expose human subjects to an experimental therapy that had not met the statutory analytical threshold of ‘highly similar,’” BIO wrote.

Both organizations have members that are pursuing biosimilars, but they mainly focus on brand-name products, including branded biologics that stand to lose significant market share when biosimilars arrive on the scene. Any delays in finalizing FDA policies on biosimilars therefore may work to their advantage.

PhRMA’s letter also suggested that the guidance is murky with respect to when clinical pharmacology data is sufficient to establish biosimilarity. For example, at one point in the guidance, the FDA said that such data “may be sufficient to completely assess clinically meaningful differences between products,” PhRMA noted.

But the guidance also said that clinical pharmacology studies, “if done well,” can complement other data and guide future testing.

“Based on these passages, it is unclear to PhRMA when FDA believes that clinical pharmacology studies can constitute the full clinical assessment,” the organization wrote.

PhRMA and BIO also sounded alarms over the FDA’s approach to safety, specifically the issue of immunogenicity, which can refer to immune system responses that cause allergic reactions or alter a biologic’s effects. The FDA’s guidance said that such data may need to be supplemented by findings from post-approval studies, and both groups expressed concern. 

BIO, for example, wrote that “full evaluation of safety and immunogenicity should still be necessary before approval” and that the FDA should elaborate on the role of post-approval studies in demonstrating safety.

Also, BIO asked the FDA to better explain its suggestion that biosimilarity may be established by looking at a single, scientifically acceptable biomarker — say, blood pressure or cholesterol levels — or at a composite of multiple biomarkers that are "relevant."

“While this approach may have utility, it runs the risk of merely increasing the quantity of data without necessarily improving the quality and interpretability of the results,” BIO wrote.

Swiss drugmaker Roche AG — parent of U.S.-based Genentech Inc. and a member of BIO but not PhRMA — also submitted a letter seeking more clarity on the four categories of similarity and complaining that the guidance covers more than just clinical pharmacology data.

According to a public docket, two dozen letters have been submitted on the guidance, but as of Wednesday, the FDA had published only four of them. Those letters were from Roche, the United States Pharmacopeial Convention, an independent board established by Amgen Inc., and generics maker Apotex Inc., which posed five questions but little in the way of criticism.

Sandoz Inc., the first company to request FDA approval along the Affordable Care Act's biosimilar pathway, didn’t immediately respond to a request for a copy of any comments it submitted. Hospira Inc., which is also pursuing biosimilars, directed an inquiry to the Generic Pharmaceutical Association, which did not immediately have comments to share.

As seen in The Hill.

Wanted: Better fact checkers at Consumer Reports

The national public debate over the misuse and abuse of opioid pain medicines has been in the news long enough now for state and federal lawmakers and regulators at the Food and Drug Administration to focus on the real issues rather than the tabloid headlines.

That’s why the latest story on the subject from Consumers Report is so puzzling. Not only is it a day late and a dollar short, but it reaches all the wrong conclusions – providing a distinct disservice to its readers.

The CR cover featuring the story screams, “Deadly Pain Pills!” But the only thing deadly is the reporting which is both hyperbolic and filled with obvious errors and selective omissions.

Specifically, CR has the pain medicine Zohydro ER in its crosshairs. The article calls on the FDA to reconsider its 2013 approval of Zohydro ER and to make acetaminophen standards consistent.

Strangely the piece fails to mention that one of the benefits of Zohydro ER is that it is acetaminophen-free. It also neglects to mention that this very concern was specifically addressed by FDA Commissioner Margaret Hamburg who testified before Congress that,  “We recognize that this is a powerful drug, but we also believe that if appropriately used, it serves an important and unique niche with respect to pain medication and it meets the standards for safety and efficacy.”

The investigative tigers at CR call for the FDA to approve only opioids that are “abuse deterrent.” Well, here’s what the FDA commissioner had to say on that subject (also in open public testimony that the CR story either missed or chose to ignore), “It doesn’t do any good to label something as abuse deterrent if it isn’t actually abuse deterrent, and right now, unfortunately, the technology is poor.”

Surprisingly absent from the CR story was any mention of the most promising of the FDA’s initiatives on abuse deterrence; a study (to be conducted by the National Institute for Pharmaceutical Technology and Education) to evaluate opioid product formulations and performance characteristics for solid and oral dosages. 

Unfortunately complex systems make for bad media coverage, while simplistic, dramatic demagoguing makes for sexier headlines.


CR also believes another reason Zohydro ER should be recalled by the FDA is that it was approved, “against the recommendation of its own panel of expert advisers.” That’s true – but it’s not the whole truth.  What the CR authors left out is that, by a vote of 11-2, the experts affirmed that there was no evidence to suggest Zohydro had greater abuse or addiction potential than any other opioid.

“Facts,” as John Adams said, “are pesky things.”

What the newshounds at CR missed completely are the issues surrounding opioid misuse – at present the poor public health stepchild of abuse. In the United States, the use of opioids as first-line treatment for chronic pain conditions doesn’t follow either label indications or guideline recommendations.

In fact, 52 percent of patients diagnosed with osteoarthritis receive an opioid pain medicine from their doctors as first-line treatment as do 43 percent of patients diagnosed with Fibromyalgia and 42 percent of patients with diabetic peripheral neuropathy.

Payers in the healthcare system often impose barriers to the use of branded, on-label non-opioid pain medicines, relegating these treatments to second line options. The result is a gateway to abuse and addiction with opioids.

Another fact conveniently missed in the CR story is that the vast majority of people who use opioids do so legally and safely. A subset, approximately four percent of patients, use these medications illegally. In fact, from 2010 to 2011, the number of Americans misusing and abusing opioid medications declined from 4.6  to 4.2 percent.

How strange that Consumer Reports missed so many facts after all this time.


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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