Acting Quickly to Safegaurd
Time is of the Essence!
Ranbaxy Laboratories, the India-based drugmaker that manufactures a generic version of the popular cholesterol medication Lipitor, has halted production of the drug amid concerns about product safety.
Ranbaxy Laboratories is the largest manufacturer of generic versions of Lipitor, and the company voluntarily recalled several dozen lots of the medication earlier this month when it was determined some of the product may have been contaminated with small, grain of sand-sized granules of glass.
Ranbaxy Laboratories is a subsidiary of the Japanese pharmaceutical company Daiichi Sankyo, and the generic Lipitor concerns are the latest of a few regarding product safety at some of the maker’s facilities, both in the US as well as India.
According to the New York Times, Ranbaxy Laboratories is currently “operating under a court-ordered consent decree,” that has been in effect since January. The paper quotes federal authorities as saying that the sanction is “unprecedented in scope” and due to some concerns about manufacturing standards as well as a conclusion that the company had “submitted false data in drug applications” to the Food Drug Administration before the decree was put in place.
FDA spokeswoman Sarah Clark-Lynn spoke to the Times about Ranbaxy’s recent issues with the generic Lipitor, and said that the affected product did not originate from “the same facilities whose conduct gave rise to the consent decree.” But in an email sent Monday, Clark-Lynn also stated that “the consent decree provides the FDA with additional tools to address violations for other Ranbaxy facilities.”
An investigation into how the glass particles came to be in the affected generic Lipitor is currently underway at the facilities from which the product originated. Ranbaxy has not disclosed which facilities may have produced the medication included in the generic Lipitor recall.
Prabir K. Basu, executive director of the National Institute for Pharmaceutical Technology and Education, told the paper that Ranbaxy Laboratories’ ongoing FDA issues are part of a larger product safety concern when manufacture of medications is outsourced to other countries. Basu opined:
“I have pretty good faith in companies and plants that make drugs in this country because I know from my own experience that they try to do a good job … But my confidence is not that high when we are getting products from outside the country.”
Basu explains that pending legislation will address issues of product standards in drug manufacturing regardless of whether medications are produced in the US or outside it, under the Generic Drug User Fee Amendments of 2012 – nicknamed Gdufa. But he admits that product safety is not an issue that Gdufa can fully guarantee:
“This is a very difficult and complex system, and how do we ensure the integrity of this supply chain? … I don’t know how much Gdufa will help.”
As an investigation into the generic Lipitor continues, the facilities from where it is believed to have originated remain closed. No injuries and no deaths have been linked to the affected batches of generic Lipitor (commonly known as atorvastatin) affected by the recall, and a shortage of the medication is not expected in the wake of the product recall.
Facebook’s ever-changing privacy policies have prompted much user concern (sometimes rightly so) when new updates are made or the social network avails itself for the first time of clauses — and this week, you have likely seen a viral and pervasive status update prompting you to protect your legal rights in the digital world by yourself reposting a cut-and-paste Facebook privacy declaration.
The Facebook privacy status meme has been spreading like wildfire — doubtlessly in part due to the fact Facebook users have been unpleasantly surprised in the past by secrets buried in Facebook’s Terms of Service or user agreements pertaining to privacy.
Given Facebook’s propensity to switch its workings around in ways that cause information “leaks” (for example, contextual ad targeting has been suggested as a possible weak spot for user data leakage), it’s not surprising that many users have fallen prey to the hope that a catch-all post to their Facebook wall citing a bunch of official-sounding statutes and terms might dissuade the social network from using their data in potentially undesirable ways.
Alas, the Facebook privacy status update currently circulating offers no protection legally, regardless of how authoritative it sounds. Ultimately, all your Facebook data — private and public alike — falls under the auspices of the site’s extensive Terms Of Service, a set of terms to which you must agree in order to become a member of the site.
Typically, end-user agreements such as this dictate how a service like Facebook is entitled to use your information, whether it is collected directly (as in, supplied by you) or indirectly, such as the information picked up by the social network in your daily Facebooking habits.
The site’s algorithms are clever and perceptive, and it’s worth noting that much of what Facebook’s dossier on you reflects may not even be the fill-in information you choose to disclose, such as marital status or location.
As it stands, there is no way to except oneself from the Facebook Terms Of Service save from abstaining from the social network altogether — certainly an unattractive prospect in this day and age.
“In response to the new Facebook guidelines I hereby declare that my copyright is attached to all of my personal details, illustrations, graphics, comics, paintings, photos and videos, etc. (as a result of the Berner Convention). For commercial use of the above my written consent is needed at all times!
“(Anyone reading this can copy this text and paste it on their Facebook Wall. This will place them under protection of copyright laws. By the present communiqué, I notify Facebook that it is strictly forbidden to disclose, copy, distribute, disseminate, or take any other action against me on the basis of this profile and/or its contents. The aforementioned prohibited actions also apply to employees, students, agents and/or any staff under Facebook’s direction or control. The content of this profile is private and confidential information. The violation of my privacy is punished by law (UCC 1 1-308-308 1-103 and the Rome Statute).
“Facebook is now an open capital entity. All members are recommended to publish a notice like this, or if you prefer, you may copy and paste this version. If you do not publish a statement at least once, you will be tacitly allowing the use of elements such as your photos as well as the information contained in your profile status updates.”
A young Kansas lawyer was fired from her job Monday after sending a tweet late last week in which she referred to the former attorney general using a common but quite vulgar descriptor.
Sarah Peterson Herr, a research attorney for a Kansas Court of Appeals judge, was in attendance at a hearing on Thursday when she sent the controversial tweet, for which she was ultimately fired.
Herr was referring to Attorney General Phill Kline, who was was appearing at the time before the Kansas Supreme Court in the course of an ethics investigation.
According to the Washington Post, Herr sent a tweet projecting that Kline, whose name was misspelled in the posting as “Phil Klein,” would be disbarred for seven years. But the other tweet, which is no longer visible on Twitter, contained the vulgarity that ultimately led to her dismissal.
““Why is Phil Klein [sic] smiling? There is nothing to smile about, [d********.]“
The lawyer later addressed the tweet for which she was fired, explaining that she had believed the comment was not viewable to the general public due to privacy settings. Herr expressed regret for the comment and its ripple effect as the story became national news.
Tom Condit, a lawyer for Kline, commented on the controversy and the lawyer who had been fired over the tweet, saying:
“I have no interest in insulting any judge or justice in that courthouse who is prepared to be fair and objective as it relates to Phill Kline … But the bigger question has always been what kind of atmosphere prevails in the back rooms of the high courts of Kansas that would make a young lady like that so comfortable to tweet those kinds of comments in those circumstances.”
By Friday, the young lawyer had been suspended with pay as the Twitter controversy erupted. On Monday, Kansas Supreme Court Chief Justice Lawton confirmed Herr had been fired over the tweet, and that possible ethics violations were being considered in the wake of the incident.