At Tuesday’s White House confab on intellectual property, Homeland Security Secretary Janet Napolitano declared that eliminating counterfeit pharmaceuticals has become a top priority for federal customs agents and prosecutors, and they expect it to remain high on their agenda next year.

This came as a surprise to many (including many at the FDA).

Nevertheless – good and important news.

According to Russell Wesdyk, scientific coordinator in the FDA's Office of Pharmaceutical Science, generic drug manufacturers would face fewer factory inspections and save as much as a year developing products in exchange for paying fees for the first time under a Food and Drug Administration proposal.

Terrifi.  The more expeditiously generic drugs can move through the FDA process the better … but not at the expense of safety.

Wesdyk shared that the FDA may waive "preapproval inspections" done after companies submit generic-drug applications. Instead, it would rely on periodic inspections that focus on firms' broader manufacturing practices.

Really?  Fewer inspections?  Isn’t that going against the prevailing philosophy that FDA needs to undertake more and more rigorous inspections and particularly overseas (where many generic products are manufactured)?

Speed is important.  Safety is more important.  To achieve both requires the agency to have more inspectors – and that means more money for the FDA.

Safe generics brought to market more swiftly?  Show me the money.

BEIJING—Big drug makers from the West are making a new kind of push into fast-growing Asian markets: creating drugs for diseases that are more prevalent there.

Within the past year, Pfizer Inc., the world's largest drug company by sales, began work in China on an anti-inflammatory compound to treat liver disease, a big killer in Asia. Health-products giant Johnson & Johnson announced last month a collaboration with a university in Beijing to research infectious diseases threatening the region. Bristol-Myers Squibb Co. also last month announced a partnership with Nanjing-based Simcere Pharmaceutical Group to develop a cancer treatment.

The approach marks a shift from the industry's history of designing medicines for patients in the West. While multinational drug makers might study experimental medicines in Asian subjects, the companies would use the clinical-trial results to gain regulatory approval in the U.S. and Europe.

Western drug makers often bypassed medical conditions specific to Asia. Liver disease, certain cancers and some infectious diseases are more prevalent in countries like China and Thailand because of differences in the environment, genetic factors and some behaviors.

Firms are now pouring into Asian markets with the goal that growth there will help them cope with pricing pressures and aging products in the U.S. and Europe. Sizable and increasing numbers of Asians can afford to buy Western drugs. About $40 billion of prescription drugs are sold in China, for instance, and the market is growing about 25% a year, according to David Maris, an analyst at CLSA, an Asia-focused investment group headquartered in Hong Kong. The pharmaceutical market in the U.S. and Europe is growing 2% to 5% a year.

Given the market's size, more pharmaceutical executives are starting to see the region's specific medical needs as potential sources of profit. U.S. and European drug makers have invested more than a billion dollars over the past year into building research-and-development and manufacturing capabilities in the area, according to CLSA.

And more investment is on the way. In announcing job cuts last month, Bayer AG said it wanted to use the savings for the "expansion of capacities in Asia," including the addition of 2,500 jobs in emerging markets.

Pfizer opened a research facility in Shanghai five years ago and established a network of doctors and academics to give input on the clinical needs of patients there. The New York company saw an opportunity in an anti-inflammatory compound that showed promise for treating liver disease. The disease can follow infection with the hepatitis B virus, which is much more common in Asia than in the West. Some 70% to 90% of people in China and some other Asian countries are infected with hepatitis B by the age of 40, compared to fewer than 20% in North America and Western Europe, according to the World Health Organization.

Johnson & Johnson's collaboration with Tsinghua University—one of the top universities in Beijing whose tree-lined campus is filled with gleaming research centers and surrounded by Chinese offices of U.S. technology giants Google and Microsoft—illustrates a partnership approach to drug R&D. The goal of the project's early-stage laboratory work is to better understand diseases like hepatitis B, tuberculosis and bird flu, paving the way for new therapies.

Since 2008, J&J has been involved in another partnership with Tianjin Medical University to improve treatment of head, neck and other cancers prevalent in Asia.

Tianjin Medical University, about 80 miles southeast of Beijing, has about 2,000 inpatient cancer beds. It is collecting tumor tissues and blood cells from each patient.

By collaborating with the university, J&J hopes to more quickly identify distinctive biomarkers, such as genes or proteins, that might signal which drugs would work best for what cancer patients, said William Hait, J&J's head of oncology.

J&J helped train local researchers on how to do detailed genetic and molecular work because they "didn't have critical mass of people with these capabilities," said Dr. Hait. The training has taken longer than expected, but the research projects are up and running, he said.

Bristol-Myers is taking yet a different approach—by licensing to a Chinese firm the development of a compound that shows promise for treating gastric, esophageal and lung cancers.

The New York drug maker sold the compound's Chinese development and marketing rights after deciding a local company could do the work more efficiently. Under the terms, Simcere will run and fund the research through mid-stage human development.

Though this might mean giving up the short-term benefit of selling any resulting products in China, Bristol-Myers can draw long-term lessons from the experience, said Jeremy Levin, who oversees transactions at Bristol-Myers. "We're learning from others in other countries," he said.

All of the drugs targeting diseases prevalent in Asia remain years off. Yet, their development can pay immediate dividends by generating goodwill with Asian patients and governments impressed by the focus on local medical needs, said Sati Sian, general manager in China of IMS Health, a drug industry consultancy.

Companies may face some skepticism from patients, however.

Mr. Chi, a 48-year-old Beijing resident who asked to be identified only by his family name, said it is a positive that Western drug companies are trying to make more new medicines but he doesn't like their focus on treating diseases more common in Asian populations with the intention of selling them first to people in China. "I would wonder why you [the company] don't start giving it to people in your country first," said Mr. Chi, a building manager.

Mr. Chi, who was waiting to see a doctor Monday because he was suffering from an upset stomach, generally prefers traditional Chinese medicines for "regulating" bodily processes, like problems with sleeping, because they are made of natural ingredients and have fewer side effects than Western medicines.

Write to Shirley S. Wang at shirley.wang@wsj.com and Jonathan D. Rockoff at jonathan.rockoff@wsj.com

Yes Virginia, there is an interstate commerce clause.  And there may yet be coal in your stocking.

As you no doubt know already, Judge Hudson found that Congress could not order individuals to buy health insurance.

In a 42-page opinion, Hudson said the provision of the law that requires most individuals to get insurance or pay a fine by 2014 is an unprecedented expansion of federal power that cannot be supported by Congress's power to regulate interstate trade.

"Neither the Supreme Court nor any federal circuit court of appeals has extended Commerce Clause powers to compel an individual to involuntarily enter the stream of commerce by purchasing a commodity in the private market," he wrote. "In doing so, enactment of the [individual mandate] exceeds the Commerce Clause powers vested in Congress under Article I [of the Constitution.]

This will largely be reported on and discussed relative to its impact on the continued viability of the Patient Affordability Act (aka “health care reform” aka “ObamaCare) – and that’s an important conversation for the 112^th Congress and others to have.  But there’s a more urgent public health imperative: uninsured, healthy young adults. 

Not that the legislation, as passed, would have accomplished anything significant about driving young, healthy people into the insurance pool.  The anemic penalties actually disincentivize youthful participation.  After all, why not pay a monthly penalty (less than even a very affordable monthly insurance premium) if, when you do face a medical emergency, you can’t be turned down or charged more?

Judge Hudson didn’t use this in any way relative to his ruling – but his ruling does give us another bite at the “young, health and uninsured” apple.

And bite we must.

If we cannot bring healthy young adults (and, for that matter, healthy adults writ large) into the insurance pool, coverage costs will increase -- and fast.  As more people with pre-existing conditions are brought into the insurance system (via state insurance exchanges, vouchers, etc.), costs will skyrocket.  The curve will be bent alright – in the wrong direction.

Thanks to Judge Hudson we have a chance to revisit a better way to address this situation – insurance regulatory reform.

A study by University of Minnesota economists Stephen Parente and Roer Feldman shows that Congress could boost by more than 12 million the number of people who have health insurance without spending taxpayer dollars. The change required is to allow people to buy health insurance across state lines, so they can shop for less expensive policies. For example, a typical health-insurance policy in heavily regulated New York costs more than three times as much as in less regulated Iowa ($388 a month versus $98 a month for the same coverage).

The penalty “stick” (whether you like it or not) will not even be an option if Judge Hudson’s ruling stands.  So we’d better start looking for some carrots – and lower cost policies is a particularly juicy one.  But that must also be paired with a strong public awareness campaign.  As any expert in behavior modification will tell you, the best way to get people to do something you want them to do is to make them understand why it is in their best interest to do so.

And the sooner the better.

FDA Floats 15-Month Review Timeline For PDUFA V; Firms Mull Tradeoff On Speed Vs. Certainty

A new report from the President's Council of Advisors on Science and Technology (PCAST) has recommended the Agency for Healthcare Research and Quality (AHRQ) receive funds above and beyond the $1.1 billion earmarked in the President’s initial stimulus package to develop a test network for comparative effectiveness research.

The report notes that if patient progress and outcomes are routinely captured in data and made available in near real time, "partial data can be used in sophisticated ways to assign treatments to new patients in optimal ways. These data also could be used to personalize treatment for patients already enrolled in a study."

“Assign treatment?” Perhaps “help a physician decide” or “provide important clinical information”  -- but … “assign?” Sounds rather top-down, don’t you think?  Alas, as this report was drafted by experts who understand the importance of precise language, we have to assume what they wrote is what they meant.

And that’s frightening.

Sounds like a good topic for a Congressional hearing.

The Council’s report can be found here.

This Sunday on "BioCentury This Week" TV

Broadcast on WUSA Channel 9 in Washington, D.C.
and Fox affiliate WFXT Channel 25 Boston
8:30 - 9:00 a.m. EST

Dec. 12 broadcast investigates
POLITICAL COMMUNICATIONS
Finding Biotech's Voice in a Divided Washington

continuous webcast at
www.biocenturytv.com

Biotech avoided the eye of the storm during the bruising healthcare reform debate. In the newly divided Washington, the question is whether the industry can afford to stay under the radar on its hot button issues, such as PDUFA, as other interest groups join the fray. On Sunday, Dec. 12, BioCentury This Week examines this political communications landscape.

I spent the last two days chairing the Social Media for Pharma conference and boy are my arms tired.

Actually, it’s my brain that’s tired – because it got a lot of exercise.

Some speaker comments that resonated:

Julie Zawisza (CDER’s Director of Communications):  “If we don’t tell our own story – others will.”

So true.  And not just for the FDA.  The same is equally relevant for pharmaceutical and medical technology companies.  Perhaps even more so.  In fact, definitely more so.

Paul Buckman, the FDA’s new Dean of Digital, revealed that there is an FDA employee who is (in real time) posting responses to queries generated on the agency’s FaceBook page.  This is surprising considering that such a thing would certainly constitute an FDA “written response.” More on this as it develops.

Ambre Morley and Alpesh Patel (product communications and regulatory affairs at Novo Nordisk respectively) discussed their much-ballyhooed Twitter campaign (for Levemir) with IndyCar driver Charlie Kimball.  At the beginning of the presentation, Alpesh said that when Ambre first discussed the idea with him, he said, “Let me think about it.” To which Ambre replied, “Actually, you said no.”  Success, as they say, has many fathers.

J&J’s always-insightful Marc Monseau shared some gems, discussing the need for well-developed social media “policy, process and guardrails.”  The most important pharmaceutical company asset for success in social media?  “A cultural willingness to try.”  Amen.

Shwen Gwee and Zach Barber (Vertex) discussed their company’s foray into Twitter – and the interesting correlation between number of tweets and number of followers.  Shwen also shared their concern over “proactive following.”  Add that one to things that make you go hmm.  (FYI – current Vertex Twitter guidelines can be found here.)

Both the Novo Nordisk and the Vertex presentations raised questions about retweets – especially those with a hotlink.  All present agreed that all links should be carefully vetted before being retweeted.  (Here’s a brainteaser – what about retweeting an FDA tweet with a product-specific hotlink that doesn’t one-click to the P.I.?  Once again – hmm.)

Relative to FDA tweets and the aforementioned FDA FaceBook – and as if things weren’t ambiguous enough – what happens when you have the federal agency in charge saying (for all intents and purposes) “do as I say, not as I do.” And, of course, this is made even worse since the FDA isn’t saying much.

But I digress.

During one of the breaks, I participated in a very entertaining conversation with three regulatory types from three different companies. We decided there is an unmet need for “regulatory emoticons.” The consensus opinion was for an emoticon representing arms crossed across the chest. We felt that a more, shall we say, digit-based representation was overly confrontational.

Nancy Buono Cartwright (Kaiser Permanente) discussed using social media as an internal communications tool. Much smart thinking and nifty program elements.  Her suggestion for engagement --“Play in traffic.”  Not the best way to encourage an already skittish audience. Auto de fé indeed!

The omega presenter was Dennis Urbaniak (sanofi-aventis) and he had a keen observation about pharma and social media, “It’s not if anymore – it’s when and how.”

He also pointed out that social media (as part of an integrated marketing strategy) is unlike other, more traditional component – such as advertising.  Social media programs are the gift that (properly understood and harvested) is the gift that keeps on giving.

What does that mean?  Well, a DTC television commercial doesn’t generate anything once it’s been aired.  Social media, on the other hand, generates awareness, interaction, a call to action (when appropriate), and robust metrics that supply real-time competitive intelligence.

Need I say more?

There were many excellent presenters who I have not mentioned.  The complete program agenda can be found here.

Fascinating and informative BioCenutury cover story on a 21t century regulatory pathway for diagnostics.  Penned by the always informed Steve Usdin, here are some snippets:

FDA and members of Congress are putting the finishing touches on different proposals to create a new regulatory pathway for diagnostics, making it almost certain that major changes will be unveiled in 2011. The question is which approach will prevail — and whether either approach solves the problem of value-based reimbursement.

Top FDA officials and lawmakers have concluded that the current oversight system for diagnostics, which imposes premarket review requirements for in vitro diagnostics (IVDs) but not for the vast majority of laboratory-developed tests (LDTs), is not sufficient to protect the public or to support the development of innovative tests that are at the heart of hopes for widespread adoption of personalized medicine.

The only option that is off the table is the status quo.

Senator Orrin Hatch (R-UT) is lining up bipartisan support — and his staff is trying to build consensus among labs, diagnostics companies and investors — on draft legislation that would preempt FDA’s efforts. His approach would create a new regulatory category encompassing both LDTs and IVD tests.

Under the Hatch bill, IVDs would no longer be regulated as medical devices. Also, FDA would for the first time routinely regulate tests performed in labs, although lab services and operations would continue to be regulated by the Centers for Medicaid and Medicare Services (CMS) under the Clinical Laboratory Amendments (CLIA) (see “BETTER at a Glance”).

Hatch hopes to use a new regulatory system to go even farther, as a platform for launching reform of diagnostics reimbursement policies, and shifting Medicare from a payment system based on the complexity of test procedures to one based on the value of tests, according to diagnostics.

FDA has clearly signaled that in the absence of legislation, it intends to regulate LDTs, fitting them into a structure that many labs and IVD manufacturers argue is ill-suited for diagnostics.

Indeed, according to Alberto Gutierrez, director of FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OVID), laboratory directors who hope FDA will back off from its plans to regulate their tests are like “ostriches which have their heads in the sand.” Gutierrez, who made the comment at a Nov. 22 meeting organized by ACLA, said the agency is writing a guidance document outlining a proposed diagnostics oversight framework. While he declined to say when the guidance will be released, FDA has already begun recruiting staff to implement it. At the same time, FDA has indicated that it will move slowly, leaving room for Congress to intervene before the agency implements any major changes.

“The success of personalized medicine depends on having accurate diagnostic tests that identify patients who can benefit from targeted therapies.”

(From July NEJM commentary jointly authored by FDA Commissioner Peggy Hamburg and NIH Director Francis Collins.)

The complete BioCentury article can be found here.

Mr. Read said, “I am honored to lead an organization with outstanding and dedicated colleagues on the front lines of medical innovation. We have a broad portfolio that spans the entire spectrum of human and animal health, from vaccines to biologics to primary care, specialty care, oncology, consumer products, nutritionals and beyond.  I have great confidence in the strength of our company and our leaders and will be looking at the performance and potential of all of our businesses to ensure we are delivering value to our customers and shareholders. We have all the elements for success -- financial strength, global reach, a disciplined focus on the therapeutic areas with the strongest growth potential and a talented and dedicated workforce.”

Since 2006, Mr. Read has led Pfizer’s Worldwide Biopharmaceutical Businesses which now comprises five global business units – Primary Care, Specialty Care, Oncology, Established Products and Emerging Markets – and accounts for approximately 85 percent of Pfizer’s annual revenues.  He was responsible for more than 40,000 Pfizer colleagues.  His leadership team consisted of senior executives directing Pfizer development and commercial operations in 180 nations.

Mr. Read joined Pfizer in 1978 and quickly assumed positions of increasing responsibility in Latin America.  In 1996, he was appointed President of Pfizer’s International Pharmaceuticals Group, with responsibility for Latin America and Canada. He was named Corporate Vice President in 2001, and assumed responsibility for Europe in addition to Canada.  Mr. Read later added the Africa/Middle East and Latin American regions to his leadership responsibility.

The Board will elect a non-executive Chairman from its current membership at its next regularly scheduled meeting that will take place within the next two weeks.

The saga continues …

NEW YORK (AP) - Momenta Pharmaceuticals Inc. said Thursday it is suing rival Teva Pharmaceutical Industries Ltd. in a patent dispute over generic versions of the anti-clotting drug Lovenox.

The Cambridge, Mass., company said it filed a patent infringement lawsuit against Teva, alleging the Israeli company violated two patents held by Momenta that are related to its generic version of the drug. Lovenox, or enoxaparin, is used to prevent dangerous blood clots, including clots in the veins of the thigh or leg, or in patients who are having a heart attack or chest pain. The original version of the drug is made by Sanofi-Aventis SA, and it was approved in the U.S. in 1993..

Nice article by Matthew Arnold in the December edition of Medical Marketing & Media.  “Eye of the Storm,” provides a nice overview of what we might expect in 2011 on a range of issues.

Here’s the section discussing the future of PCORI (the Patient Centered Outcomes Research Institute):

Healthcare reform rematch

Ex-FDA communications chief Peter Pitts says the board “provides the grease on the slippery slope towards formularies.” Three of its 21 seats are dedicated to pharmas, with execs from Pfizer, J&J and Medtronic among the initial appointees. Congress could also pull the $1.1 billion allocated to the Agency for Healthcare Research and Quality for comparative effectiveness research by the law.

“That money will be radically reduced if not eliminated altogether,” predicts Pitts. Pitts also expects “a very colorful season for healthcare hearings on the hidden codicils of healthcare reform.”

The full article can be found here.

Talk about a doc fix!

News from the AMA. But not really “news,” in the sense that everyone knew this already.  Nevertheless …

 New AMA Survey Finds Insurer Preauthorization Policies Impact Patient Care

Chicago – Policies that require physicians to ask permission from a patient's insurance company before performing a treatment negatively impact patient care, according to a new survey released today by the American Medical Association (AMA). This is the first national physician survey by the AMA to quantify the burden of insurers' preauthorization requirements for a growing list of routine tests, procedures and drugs.

"Intrusive managed care oversight programs that substitute corporate policy for physicians' clinical judgment can delay patient access to medically necessary care," said AMA Immediate Past President J. James Rohack, M.D. "According to the AMA survey, 78 percent of physicians believe insurers use preauthorization requirements for an unreasonable list of tests, procedures and drugs."

The AMA survey of approximately 2,400 physicians indicates that health insurer requirements to preauthorize care has delayed or interrupted patient care, consumed significant amounts of time, and complicated medical decisions. Highlights from the AMA survey include:

·         More than one-third (37%) of physicians experience a 20 percent rejection rate from insurers on first-time preauthorization requests for tests and procedures. More than half (57%) of physicians experience a 20 percent rejection rate from insurers on first-time preauthorization requests for drugs.

·         Nearly half (46%) of physicians experience difficulty obtaining approval from insurers on 25 percent or more of preauthorization requests for tests and procedures. More than half (58%) of physicians experience difficulty obtaining approval from insurers on 25 percent or more of preauthorization requests for drugs.

·         Nearly two-thirds (63%) of physicians typically wait several days to receive preauthorization from an insurer for tests and procedures, while one in eight (13%) wait more than a week. More than two-thirds (69%) of physicians typically wait several days to receive preauthorization from an insurer for drugs, while one in ten (10%) wait more than a week.

·         Nearly two-thirds (64%) of physicians report it is difficult to determine which test and procedures require preauthorization by insurers. More than two-thirds (67%) of physicians report it is difficult to determine which drugs require preauthorization by insurers.

Preauthorization policies deliver costly bureaucratic hassles that take time from patient care. Physicians spend 20 hours per week on average just dealing with preauthorizations. Studies show that navigating the managed care maze costs physicians $23.2 to $31 billion a year.

"Nearly all physicians surveyed said that streamlining the preauthorization process is important and 75 percent believe an automated process would increase efficiency," said Dr. Rohack. "The AMA is urging health insurers to automate and streamline the current cumbersome preauthorization process so physicians can manage patient care more efficiently."

See these two new papers from Health Affairs:

Peering Into The Black Box: Billing And Insurance Activities In A Medical Group