Generic Drug Patent Settlements

Posted on: October 23, 2009  |   Author: Ali
Filed Under: Drug & Device, Health I.P., Life Sciences, Other, Tax & Finance   |   Leave a Comment

Generally, most patent lawsuits are resolved when the accused infringer agrees to pay money to the patent rights-holder.  However, in patent infringement suits involving generic pharmaceutical manufacturers these agreements sometimes follow a different path.  Occasionally, the patent-holder will give the generic drug manufacturer money to delay the release of the generic drug (the Federal Trade Commission calls this a “pay for delay” deal).

These payments ultimately delay the introduction of generic drugs and FTC Chairman Jon Leibowitz estimates that “pay for delay” deals cost consumers, insurance companies, and the federal government spends an additional $3.5 billion each year (the drug manufacturers dispute this estimate).

The first example of this kind of deal was in 1994 when Bristol-Myers Squibb paid Schein Pharmaceutical $290 million to delay the sale of a generic version of Bristol’s Buspar, anti-anxiety drug.  Recently, drug purchasers, including CVS Caremark Corp. and Rite Aid Corp., challenged an agreement between Bayer AG and Barr Pharmaceuticals Inc. where Bayer paid Barr to delay producing a generic version of Cipro, an antibiotic drug.

In July, the Department of Justice stated that these kinds of settlements are “presumptively unlawful”.  Last week, the senate judiciary committee voted 12 to 7 to forbid these deals.  President Obama also supports a ban.

ABC News, October 15, 2009; Wall Street Journal, July 6, 2009; PatentlyO, October 16, 2009.

Does Chantix fit into Health Reform?

Posted on: October 22, 2009  |   Author: Blake
Filed Under: Access to Care, Drug & Device, Health Information, Healthcare Reform, Life Sciences, Medicaid, Medicare, Other, Tax & Finance   |   Leave a Comment

As the health reform debate continues, the headlines are dominated by discussion about the cost of reform, the public option, insurance exchanges, and an individual mandate, but what about some of the minutiae that is involved. Some of these less talked about changes could have potentially large effect on those involved.

For example the health care bill that the Senate Finance proposed last week requires Medicaid programs to pay for smoking cessation drugs, such as Pfizer’s Chantix and GlaxoSmithKline’s Zyban. Currently, states can choose whether or not their Medicaid program will pay for these types of drugs. Approximately three quarters of the states now include some smoking cessation coverage with their Medicaid program, however the policies vary and are sometimes limited to 90 days of treatment.

It probably comes as no surprise that cancer advocacy groups and the drug industry are supporters of the Senate Finance bill. A spokesman for the American Cancer Society said the group would like to see similar mandates with Medicare and private insurance as well.

Commentary: According to the American Caner Society, tobacco use is responsible for nearly 1 in 5 deaths in the United States and smoking is the most preventable cause of premature death in our society. Therefore it’s hard to hard to argue against Congress requiring the states to cover smoking cessation products on their Medicaid formularies.

However, I would be surprised if Chantix was required to be covered by Medicaid. On one hand, Chantix has a unique mechanism of action compared to that of other smoking cessation aids, but its efficacy is still being questioned. Although studies have shown Chantix had a substantial benefit, some argue the methodology of these studies was flawed. Additionally, the FDA has required that Pfizer put a boxed warning on the prescribing information of Chantix that warns people about the psychiatric side effects that are associated with the drug. Unlike many of the other smoking cessation products, Chanix is not available in a generic form and therefore carries a much higher cost.

That said I’m not advocating that Chantix is a bad drug or is ineffective, but rather I’m suggesting that Congress should be careful where they choose to set their minimal requirements with regards to smoking cessation products. With questions looming about efficacy, a substantial side effect profile, and such a high price tag, I would be more in favor of leaving it up to each state to decide if they want to add this drug to their Medicaid formulary.

The Wall Street Journal, October 16, 2009

FDA Drug Labels: Not Telling the Whole Story?

Posted on: October 22, 2009  |   Author: Jamie
Filed Under: Drug & Device, Health Information, Life Sciences   |   Leave a Comment

Experts from Dartmouth College pushed for more stringent labels on prescription medications approved by the FDA in an article of the New England Journal of Medicine.  Drs. Lisa Schwartz and Steven Woloshin feel that the current labels on prescription drugs in the United States do not give the public or doctors a full view of the considerations conceived by the FDA while approving drugs for sale, often playing up benefits and playing down side effects.

The reason for this, the experts say, is because the drug labels are written by the drug manufacturers themselves as opposed to being written by the FDA.  The information on the labels is often comprised from results of company studies comparing the results of those taking the drugs with those taking placebo pills. The FDA bases its criteria for approval of a drug based upon its effectiveness outweighing its risks, and if it so finds, approve the label written by the drug company reflecting such a finding. These labels however, often leave off risky side effects of the drugs. The experts use the example of Novartis’ Zometa, a drug used to “prevent skeletal fractures in cancer patients with brittle bones.” The higher 8 mg dose of the drug was approved by the FDA in 2001 and marketed without a label warning against increased kidney damage and death as found by the FDA in its pre-approval findings.

Although this information can be obtained in the FDA internal reviews which are published online, they are often extremely lengthy and written in medical language difficult for most lay people to understand. Drs. Schwartz and Woloshin want the FDA to provide summaries of these reviews which can be quickly read and easily understood by the public, in order to provide knowledge of the full range of side effects when read in combination with the drug labels. The FDA’s own panel of communication experts has adopted a similar idea, urging the FDA to adopt fact boxes for all announcements about drug risks and benefits.  Drs. Schwartz and Woloshin demonstrated fact boxes to be an effective tool in a study in 2006 where 70% of patients viewing fact boxes correctly identified a superior medication versus only 8% viewing traditional advertisements.

Commentary: People need to be self educators. Citizens of this country should not rely on others to get them the pertinent information they need, especially about something so important as their personal health, People need to take the initiative to seek out such medically pertinent information for themselves.  That being said, people can only go so far when given limited tools with which to search.  The current labels of FDA approved drugs are supposed to be the place to go, the source to seek out, when looking for pertinent drug information such as side effects and medication interactions. If the important medical information is not contained in the drug labels, one does not have many other practical options in the way of sources to find such information. The FDA needs to include information about drug side effects, death rates, and adverse findings on drug labels in order for people to be able to make the medically responsible decisions that the government in turn expects them to make.

msnbc.com, October 21, 2009.

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