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Looking for a great job? How about Director of Communications for CDER?
Here are the details:
FDA's Center, for Drug Evaluation and Research (CDER) is searching for exceptional candidates for the position of Director of the Office of Communications (OCOMM). The Office currently has over 100 employees. OCOMM is the central hub for communication expertise, in CDER, focused on the development of consistent messaging to inform and educate the multiple audiences. The Office has a variety of responsibilities including the planning, coordination and evaluation of the policies, procedures, programs in the strategic outreach and communication about drug-related requests.
The incumbent serves as Director, Office of Communications (OCOMM) for the Center for Drug Evaluation and Research (CDER). The Director provides leadership and direction for all Center internal/external communications. The Director is responsible for the creation of a climate for cooperative work relations, and support and understanding of the CDER program objectives. Additionally, the Office of Communications Director advises and counsels the Center Director and CDER leadership on external and internal communications relative to the exchange of information and is the liaison external groups.
Qualifications:
Applicants should possess an advanced degree in Communications, Marketing, Public Relations, or Public Affairs.
Successful candidates are those that have experience working closely with highly-credentialed people. They must have substantial experience in Communications, Marketing, Public Relations, and/or Public Affairs. Knowledge of pharmaceuticals is a plus. The candidate should be persuasive, influential, and have the ability to ask the right questions.
Location: Silver Spring, Maryland
Salary: GS-15, $124,995-157,100 Salary is commensurate with qualifications and experience. A full Federal benefits package is also available including: leave, health and life insurance, retirement, long term care insurance, and Thrift Savings Plan (401K equivalent).
Much chatter about a pending FR notice announcing an FDA public meeting on pain medications. Good idea or bad idea?
Well, as the Beltway saying goes, where you stand depends on where you sit. On the one hand there’s the side of science and the public health. Is open public debate useful? Absolutely. And timely.
On the other there are those with less than altruistic interests. The tort bar for one and ambitious politicians for another.
What does “success” look like? For the FDA and like-minded public health advocates, success means advancing safer and more safely used pain medications. For learning and accelerating applied science.
For others it means headlines and a hefty payday.
Which story is more media-friendly? If you don't know the answer to that one, do some internet research on the vaccine/autism link and the debate over SSRIs and teen suicidal ideation.
(Hint – science doesn’t win media inches.)
Who will testify at the FDA meeting? Who will serve on the expert panels? Who will the FDA participants be?
It’s good news that the session will not be an advisory committee. No votes are likely to be taken. Nor will it probably be a Part 15 affair where only “listening” is required of the agency.
It’s FDA leading – but the devil is in the details.
Enoy the paper -- and have a great Labor Day.
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
Summary
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.
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.
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.
