Latest Drugwonks' Blog
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.
Here’s the kicker:
Read the entire article here.
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 112th 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.
Sally Greenberg (National Consumer's League) and I discuss health care and the 112th Congress:
Part 1
Part 2
And here's a segment on where we might see health care communications venture.
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.
Policom Basics -- Gene Grabowski, SVP at Levick Strategic Communications, and Wayne Pines, President of Regulatory Services and Health Care at APCO Worldwide, warn that biotech must make its voice heard. |
Enjoy!
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.
