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The Controversial Death Of A Sanofi Sales Rep
Early on a Sunday morning in July 2010, a Sanofi sales rep named Kang was driving a medical school professor to a planned golf outing in South Korea. But then, tragedy struck. An accident ensued and Kang was killed; the professor was harmed, but survived. The Kang estate later maintained this was a work-related death and sought to receive compensation from the Korea Labor Welfare Corporation.
This is where things got a little sticky, though, and have placed the drugmaker on the defensive. Media reports indicated Sanofi argued the death was not related to official work. Why? Although Sanofi never “presented a report insisting that the death of the employee is not a work-related accident,” the drugmaker never “directed the employee to a golf entertainment, nor approved such an activity,” according to a statement sent to us. In other words, Kang was free to golf with the professor, but this was not sanctioned as part of his responsibilities.
The explanation suggested that Kang was not entitled to compensation, since he was not officially on the job when the accident occurred. And so the Korea Labor Welfare Corporation rejected a claim by the Kang family, which argued that Kang was taking the professor to play golf because such an activity was, in fact, part of his job. The family subsequently filed suit and, last week, the Seoul Administrative Court ruled the KLWC will have to cover funeral costs and make a condolence payment.
“Kang clearly seems to have died while operating official sales business, and his death is an industrial accident. Even though there is little evidence corroborating the company ordered a golfing treat, literally, it winked at it, covering (golf) treating costs (and) disguised them as lunch or dinner for Kang,” the court ruled, according to one South Korean media report.
Here is the issue. The pharmaceutical industry, you may recall, has tried to be more cautious about interactions with physicians after the Korea Fair Trade Commission began a crackdown a few years ago. Last fall, for instance, Sanofi was one of six drugmakers fined for organizing free seminars and conferences for doctors, clinics and hospitals; offering golf outings; carpets; wine; dinners; speaking and consulting fees; spa treatments; movie showings and old-fashioned cash for purportedly conducting post-marketing surveillance (read here).
For this reason, the South Korean media reports also suggested that Sanofi somehow submitted falsified information on the accident report in order to avoid not only liability, but also repercussions from regulators. Not surprisingly, Sanofi has taken exception to the reports and a spokesman tells us that the drugmaker did not fabricate any information pertaining to the accident.
The following statement was sent from Sanofi offices in South Korea by way of the spokesman: “It is true that during the process of dispute between the bereaved family and the KLWC, the company has written and provided the document based on the facts that the company has captured at that time, but did not ever distort the details of the accident.
“The accident happened in July 2010, when our customer was at the employee’s car. Taking it into consideration, the company has made utmost efforts to support the bereaved family to receive compensation from the KLWC by providing related information and assistance. Moreover, the company has never claimed that the death of its employee is not work-related.”
Nonetheless, the episode has clearly made Sanofi officials uncomfortable. Although the accident occurred before the latest regulatory enforcement effort by the KFTC, the unfortunate death of the sales rep is a reminder that drugmakers are under increased scrutiny and the golf outing was a likely example of why regulators have remained so interested in pharmaceutical marketing.
golf pic thx to chispita_666 on flickr
House Democrats Probe ADHD Drug Shortage
For much of the past year, various meds for attention deficit hyperactivity disorder have been in short supply. The lack of pills, such as Ritalin and Adderall XR, have caused a highly disruptive problem for children and their parents, much like the ongoing shortages of generic injectable medications have wreaked havoc at hospitals and clinics (back story).
However, the dearth of ADHD pills has engendered a fingerpointing blame game between two federal agencies. The FDA says the shortages are due to unnecessarily strict quotas set by the US Drug Enforcement Agency. In turn, the DEA suggests drugmakers may be at fault for making more of the higher-priced brand-name versions than generics, which throws supply and demand out of whack.
“We have reached out to the DEA and told them that there are shortage issues, but the quota issues are outside of our area of responsibility.” Valerie Jensen, associate director of the FDA drug shortage program told The New York Times recently. But DEA Special Agent Gary Boggs, who works in the Office of Diversion Control, argued that “we believe there is plenty of supply.”
Indeed, Novartis sells brand-name and generic versions of Ritalin, while Shire does the same for Adderall XR. Both companies have insisted they have attempted to meet demand while working with the DEA on quotas. But the confusion has irked some members of Congress and now four House Democrats have written the DEA and the drugmakers to improve supplies and availability.
The letters to the drugmakers charge that supplies of the brand-name versions may be given preference over the generics, which can yield lower profits, but “the effect of this policy could be to force consumers who need (Adderall XR or Ritalin) to pay for an expensive brand-name product rather than a less-expensive generic drug” (here is the letter to Shire ceo Angus Russell and the letter to Novartis ceo Joe Jimenez.
And so the Democrats – House Energy and Commerce Committee ranking member Henry Waxman; Subcommittee ranking members Diana DeGette and Frank Pallone, Jr., and Budget Committee Ranking Member Chris Van Hollen – want the drugmakers to cough up info on DEA quotas; actual production output; wholesale acquisition cost data; Medicaid reimbursement figures and internal documents on policies concerning production of the brand-name and generic ADHD meds.
Similarly, they asked the DEA for information on how it sets quotas for the pills; any analysis the DEA has conducted to determine availability and why patients have reported difficulty obtaining the meds; a summary of the effect that quotas have had on supplies; a report on the extent to which the DEA considers business decisions when setting quota policies, and any changes the DEA may consider.
“We consider data from many sources when we look at quotas. What most people don’t realize is that we don’t issue quotas for products, we issue the quota for the active ingredient, which is amphetamine salt… We look at legitimate medical needs, prescriptions dispensed, manufacturer disposition and forecasts, our own tracking data from wholesalers. We actually increased quota for amphetamine salt by 30 percent for 2012,” DEA spokesman Rusty Payne tells us.
“We’ve always maintained there was enough quota available. What we saw was a depletion of reserves. Manufacturers are allowed to carry over any excess, but that was becoming depleted, hence the increase in quota. We still maintain these companies have multiple products and its their decision how to allocate production and those are business decisions. We don’t get involved in that nor should we. And we don’t control those decisions.”
A Novartis spokeswoman writes us to say that the drugmaker has received the letter. “We take this matter seriously and intend to cooperate fully with the inquiry. We are also working diligently to increase supply of our generic ADHD medicines to meet customer demand and are committed to helping ensure the appropriate patients have the ability to fill their prescriptions.”
We have asked Shire for comment and will update you accordingly. Meanwhile, a spokeswoman for the House Energy and Commerce Committee says similar letters may go out to drugmakers that sell still other ADHD meds if reliable information becomes available to suggest that product shortages for those meds also exist.
