Latest Drugwonks' Blog
From the pages of the Detroit News:
Foreign patent abusers undermine U.S. drug industry
The biggest roadblock to American pharmaceutical innovation isn’t science. It’s intellectual property rights.
Drug companies are struggling to finance the research and development of new treatments. And their difficulties are being seriously exacerbated by some of America’s closest trading partners. Foreign officials are repeatedly violating basic intellectual property protections and siphoning away valuable investment capital.
These abuses need to stop. The drug industry is a crucial part of the American economy. We can’t afford for it to cease innovating.
The largest drug companies typically invest over one billion dollars to develop a new medication. The drug development process usually takes 10 to 15 years. And many of these investments don’t pay off. Only about a fifth of the 5,000 compounds that enter pre-clinical testing every year even make it to human trials. And among those only one in five will ever get approved by the FDA.
Pharmaceutical companies are willing to undertake such costly risk because they hope to eventually recoup these investments once the drug is approved by the FDA. Patents provide innovators with a limited period of market exclusivity, in which competitors are barred from creating low-cost knock offs. The resulting sales help offset those massive upfront expenses.
But these patent protections are now under threat by some major U.S. trading partners.
Our neighbor to the north, Canada, has established uniquely burdensome hurdles for pharmaceutical patent-seekers. Usually, a company seeking a foreign patent must simply prove that its product is useful and new. But Canada demands that patent-seekers overcome an additional hurdle, in which they must “soundly predict” with a high level of specificity the underlying product’s ultimate function.
This creates a Catch-22 for pharmaceutical developers.
In order to “soundly predict” the use of a new medicine, they must gather extensive evidence from clinical trials. But by the time this lengthy trial process is completed, the drug is no longer exotic or new — and so it may no longer meet the “novelty” standard.
Canadian courts have embraced this double-bind and overturned the patents for more than 20 innovative medicines in the last decade. And even more drugs might be at risk of losing their patent protections. Canadian regulators are still allowed to revoke patents years after they’ve been awarded.
India, another major American trading ally, has also undermined the intellectual property rights of pharmaceutical companies. Indian courts have revoked or otherwise broken at least 14 drug patents in the last two years.
For example, although Pfizer’s cancer drug Sutent enjoys patent protections in 90 countries, Delhi recently revoked its patent. A judge unilaterally ruled the drug wasn’t sufficiently “inventive.” Regulators have invoked equally suspect grounds for snapping patents in other decisions, including the need to protect domestic manufacturers.
These patent violations undermine long-term drug innovation. By carving into companies’ ability to recoup its R&D investments, they reduce the funds (and the appetite) for new medical exploration. Firms will be less likely to take that huge risk entailed by the creation of breakthrough treatments and the supply of new life-saving drugs will diminish.
Peter J. Pitts, a former Food and Drug Administration associate commissioner, is president of the Center for Medicine in the Public Interest.
Thought provoking lead story in this week’s edition of BioCentury, Back to School Issue: Paying the piper. Here’s the challenge:
Pharma has lost its pricing power in many countries, as evidenced by reimbursement authorities' willingness to delay or outright deny access to drugs whose costs are deemed unacceptable. Now, the availability of a costly drug in the U.S. that could be given to millions of people has sparked the strongest backlash against drug pricing the industry has yet faced - in the last major market where the government has not adopted any form of drug price controls, according to the U.S. Department of Commerce.
Last year, in "Facing Reality," Back to School argued biopharma companies can no longer assume the market will support premium pricing, even for drugs that deliver meaningful and measurable improvements over the standard of care.
This year, BioCentury's 22nd Back to School essay goes on to argue that the last bastion of free pricing is crumbling, and biotech and pharma had better start experimenting with new pricing models based on value for money while they still have the chance.
And here’s the conclusion:
Back to School does not suggest drug pricing and reimbursement can be fixed easily, and certainly not by the drug industry on its own. Finding approaches that will get new and better medicines to patients sooner, that compensate companies for the health benefits their drugs provide and that don't break the bank will come only through vigorous and collaborative experimentation.
Nevertheless, unless it pursues experiments with the explicit goal of creating a win-win for payers and patients as well, the drug industry can expect controls on prices and utilization to be applied with indiscriminate force in markets worldwide.
Biopharma's brightest minds are hard at work discovering and developing breakthrough medicines. It will be a pitiful shame if patients are denied access because the industry's brightest marketing minds are not creative enough to devise models that will enable healthcare systems to pay for these transformations in healthcare.
What industry needs are brave individual first-movers to get to work on new pricing models that will preempt a cost-plus system and preserve incentives for innovation.
Back to School has described three places where drug companies can blaze the trail.
First, they should pioneer value-based approaches that wed drug prices to the patient- and payer-defined value of outcomes, rather than to the volume of drugs consumed or, in the emerging worst case scenario, the costs to develop and produce them.
Second, drug companies should take the lead on making risk-sharing a reality, not just a catch-phrase for discounts and rebates, and make investments in the kinds of enabling systems that can support appropriate use and reimbursement of medicines, as well as inform development of tomorrow's innovative drugs.
Third, drug companies should spearhead the development of payment models that enable health systems to absorb the cost of cures by enabling payment over the period in which benefits accrue, as long as the drugs continue to work.
As has been the case with Back to School's recommendations in years past, these experiments will require robust collaboration with unfamiliar and even hostile partners. Many will fail.
But the reward for taking those risks will be a menu of pricing and reimbursement options that ensure companies are compensated for the value of both incremental and breakthrough innovations, and that drive revenue and profit by extending access to a bigger pool of patients.
The entire article (and it is definitely worth a read) can be found here.
Via Fierce Pharma – and they buried the lead
EU agents seize more than €10M worth of counterfeit drugs, arrest 12
Authorities from 8 European Union countries, backed by Europol and Eurojust, have arrested a dozen suspects and seized more than €10 million worth of counterfeit drugs, mostly fakes of erectile dysfunction drugs that an organized crime group was selling online. The raid, announced Monday, came after an investigation that lasted nearly two years.
According to Europol, law enforcement folks from Austria, Belgium, Cyprus, France, Hungary, Slovakia, Spain and the United Kingdom conducted simultaneous raids. They were backed up by Europol and Eurojust. In addition to seizing several million pills, which it estimated were worth well in excess of €10 million, the agents seized cash and luxury cars and froze bank accounts that contained €7.5 million.
The investigation originated in Spain, which was able to provide information for probes in Austria, France and the U.K., Europol said in a statement. It said the fakes originated in Asia, home to many of the counterfeit drug operations.
While erectile dysfunction drugs have long been a target of counterfeiters selling online, Europe is also seeing organized crime move into stealing and faking high-priced drugs, like cancer meds. Authorities this spring warned that vials of Roche's cancer med Herceptin that had been stolen in Italy were showing up across the continent with little or none of its active ingredient.
Because some of the organized crime rings behind counterfeits are based in Europe, the FDA has assigned one of its criminal investigation officers to Europol in The Netherlands. The FDA estimates that 40,000 to 60,000 domain names could be tied to illegal online pharmacies at any given time, and that this number is in a constant state of flux.
Not mentioned in the article – but of relevance – is that in 2013 US National Association of Boards of Pharmacy found that only 257 of 10421 online pharmacies are legally legitimate businesses (less than 2.5%). The remainder either have bogus registration credentials or domain names that make them “suspect.”
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.
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.
