The Centers for Medicare and Medicaid Services (CMS) released guidance back in December regarding the implementation of the Federal Sunshine Law and the proposed timing. Since then, the timeline for formal introduction of the law has been revised by CMS, delaying how soon those manufacturers must begin to collect data for their reports. Rather than requiring the collections to begin on January 1st, CMS will not require them to begin until the issuance of the law’s final ruling.
This law will require manufacturers of drugs, biologics, devices and medical supplies covered under Medicare, Medicaid and the Children’s Health Insurance Program to report payments and other transfers of value made to physicians Read more…
A recent New York Times article highlighted the fact that there are “critical shortages of drugs to treat a number of life-threatening illnesses, including bacterial infection and several forms of cancer” and that “clinical trials for some experimental cures have been delayed”.
Unfortunately, this type of delay or interruption may not fall within the scope of a sponsor’s insurance coverage. The reason is that traditional business interruption coverage is triggered only when the interruption is caused by direct physical loss or damage to a sponsor’s facility, i.e., their lab, office or manufacturing location. Another coverage that may come into play is “contingent business interruption”. Also triggered by direct physical loss or Read more…
Thanks to the explosion of social media networks like Twitter and Facebook, drug and medical device companies now have a direct link to users of their products. Although the U.S. Food and Drug Administration (FDA) addresses legal and regulatory issues associated with off-label promotion medical devices and drugs, it has only recently directed enforcement towards companies that who are utilizing these new mediums to promote their products.
Many Product Liability policy forms contain an exclusion for loss arising out of the dissemination of information in violation of any law, regulation or order of any governmental authority. It will be interesting to see how insurers will address social media and if they will consider using these new mediums a form of off-label promotion. Ropes & Gray LLP will host a webinar tomorrow on the regulatory challenges posed by social networking and online media tools, to explore FDA’s approach to enforcement in this area and provide practical advice for companies to consider when developing their compliance strategies. Check it out “Using Social Media Outlets for Drug Promotion“.
A report in the New York Times reviewed a position in the New England Journal of Medicine it called “unusual” – arguing two sides of a medical point in one issue. The study in question was about a new blood thinning medicine which was proven to be effective but at significant cost. It would make a difference to one person in 88 at a cost of $180,000 for those 88 persons. The improvement in outcome did not save lives but rather prevented great though temporary pain in one person.
This type of analysis is likely to increase as the federal government, and those who feed the debate like the New England Journal of Medicine, will look more and more to cost effectiveness. This is not a new issue in other Western countries that routinely review new drugs for these efficiencies. But, in the United States, this is often viewed as health care “rationing”, putting limits on individual freedom to receive all of the health care that they want from their providers, drug makers and health insurers.
According to the Department of Justice, Allergan made it a “top corporate priority” to maximize sales of Botox for off-label uses by employing illegal marketing tactics. Those tactics included 1) calling on providers who typically treated patients with Botox for off-label conditions, 2) conducting workshops on how to bill for off-label uses of Botox and 3) operating a hotline that provided free on-demand services to doctors for off-label uses. In addition, Allergan lobbied government health care programs to expand coverage for off-label uses, officials said.
Pharmaceutical companies should be aware of the fact that bodily injury claims resulting from off-label promotion may not be covered by their Product Liability insurance. Read more…
Effective 9/1/10, there are changes to the Federal Drug Law pending in Russia that will have a material effect on the approval and management of clinical trials that are being conducted there. The changes are related to the regulatory approval process being transferred from the Federal Service on Surveillance in Healthcare and Social Development to the Ministry of Health and Social Development. The majority of this criteria is related to investigator sites, mainly to contracts with investigators, investigator experience, patient consents and insurance amounts. Unfortunately, the current version of the law is full of inconsistencies and requires further clarification. Many CROs are still evaluating how these changes will affect studies (specifically on start-up operations) and continue to report any new developments. The relationship between the Insurer, Insured (sponsor) and the Patient (test subject) will be defined in these new proposed regulations which are still pending approval by the Government of the Russian Federation. At this time no such “regulations” have been approved and this continues to be closely monitored.
Yesterday’s New York Times describes possible harm to customers of biotechnology giant, Genzyme Corporation, arising out of the reduced availability of Genzyme’s products as a result of a plant shutdown caused by a virus contamination at Genzyme’s plant. The story relates that such a viral contamination is not uncommon in the production of biological products. The inability to supply life-saving drugs that have no easy replacement from other manufacturers, not surprisingly, may have led to adverse outcomes for Genzyme’s patients and this type of exposure to harm exists for many other drug and device manufacturers. Read more…
Various year-end securities litigation studies have shown exactly what one might expect, that cases involving financial services companies have dominated securities lawsuit filings for the last few years. What is surprising though is that plaintiffs’ attorneys have continued to pursue claims against companies in other industries, specifically the life sciences. Read more…
A decree goes into effect March 14th requiring minimum insurance for any company conducting clinical trials in Italy. The new requirements were established by Italy’s Ministry of Labor, Health and Social Policy to safeguard participants in clinical trials conducted wholly or in part in that country.
The requirements state that the insurance policy must cover any civil liability of the sponsor and investigator without excluding any damage which may have been caused by accident or attributed to negligence. In addition to death and permanent and/or temporary injury, damages include economic loss directly resulting from participation in the clinical trial. Read more…
The Centers for Medicare and Medicaid Services (CMS) released guidance back in December regarding the implementation of the Federal Sunshine Law and the proposed timing. Since then, the timeline for formal introduction of the law has been revised by CMS, delaying how soon those manufacturers must begin to collect data for their reports. Rather than requiring the collections to begin on January 1st, CMS will not require them to begin until the issuance of the law’s final ruling.
