Children's Online Privacy Protection Act-Novartis Pharmaceuticals Corporation-Personally Identifiable Information

Have You Met Turbo "Scott? FTC May Want to Meet this eBook for Children Sponsored by Novartis

I just found this tweet from @Novartis:
"US only: Have you met Turbo & Scott? Visit http://t.co/yJDtSvhQ to read the TSC eBook or download Barks and Crafts"At first, I thought this would be some kind of Rx branded Web site because it was for "US only," which usually means there's some direct-to-consumer (DTC) Rx product information on the site or closely linked to it. But there isn't any hint of a drug mentioned anywhere that I can find.
It's really a site designed for young children who have TSC, "which stands for three big and hard-to-pronounce words, Tuberous Sclerosis Complex."
NOTE: Novartis probably markets the only drug approved by the FDA for treatment of TSC (see press release). Hence, even though the drug is not referenced on this site, FDA may regulate the site as if it were marketing that drug. European regulators also may feel that the TSC site violates their regulations regarding DTC communications.The eBook is beautifully illustrated and written in the simple language that a child would use. In fact, it's a story told by Turbo, the stuffed dog friend of Scott who is "a real boy and [Turbo's] best friend." Scott has TSC.
I've never heard of TSC before, but apparently, it is a pretty serious hereditary condition that can cause seizures and may require Scott and other kids with TSC to be examined and treated by as many as SEVEN different specialists: Neurologist, Ophthalmologist, Pulmonologist, Nephrologists, Psychiatrist, Cardiologist, and Dermatologist. That's a lot of "gists!" The ebook does a good job explaining to kids what these doctors do.
But what the site does NOT do well is comply with the U.S. Children's Online Privacy Protection Act (COPPA). COPPA "applies to operators of commercial websites and online services directed to children under 13 that collect, use, or disclose personal information from children." Such sites may not collect personally-identifiable information from children without the consent of parents (see COPPA FAQs).
The URL in the tweet above resolves to this URL: http://www.tuberous-sclerosis.com/patient/ebook/ebookhome.jsp which displays this page:
There is a notice from Novartis at the bottom of the screen, which states "Use of this website is governed by the Terms of Use and Privacy Statement. Copyright ©2012 Novartis Pharmaceuticals Corporation. All rights reserved."
The privacy statement clearly states that "Novartis will not knowingly collect, use or disclose personally identifiable information from a minor under the age of 13, without obtaining prior consent from a person with parental responsibility (parent or guardian)." However, any child (including me) can click on the "Send to Friend" tab and enter his/her name and email address as well as the email address of a friend:
Novartis says "The email addresses you furnish will be used solely to notify the recipient of the link to this page and that you have requested it to be sent. The addresses will not be retained or reused." Since the information is not "retained of reused," this "Send to Friend" feature may be eligible for the "one-time exclusion" allowed by COPPA.
However, another feature of the site allows children to send an email message directly to TSC.Story@novartis.com.
On that page Novartis says: "TSC.Story@novartis.com is to be used to show your interest in further information. We look forward to receiving your email. The personal email information you submit will be used to deliver information about TSC and the TSC eBook program only. By submitting your information you agree to receive information via emails. Please be assured that although we share your information with third parties who work for us on these activities, neither Novartis nor third parties working on our behalf will sell or rent your personal email information. You may unsubscribe at any time by clicking here and specifying Unsubscribe in the subject of the email."
This is clearly an attempt t read more..

Novartis Pharmaceuticals Corporation-Professional Women-Phil Keoghan-Awareness-Cyclists

TV host Phil Keoghan and professional women cyclists join Novartis to raise awareness of multiple sclerosis

EAST HANOVER, N.J., May 8, 2012 /PRNewswire/ -- Phil Keoghan, host of "The Amazing Race," and the women cyclists of the professional "NOW and Novartis for MS" team are joining with Novartis Pharmaceuticals Corporation for a second year in a row to raise awareness of MS. The campaign,... read more..

source:http://www.pharmainfo.net

Intellectual Property-Compulsory License-Indian Government-Natco Pharma-Patent Case

U.S. questions India's IP regime after Nexavar move

Is intellectual property safe in India? That's the question drugmakers--and now U.S. officials--are asking, as the country's top court considers a landmark patent case, and after the government ordered its first compulsory license on a Big Pharma-patented drug.The issue drives to the heart of pharma's push into emerging markets; after all, if innovative drugs aren't protected, then how can the makers of those drugs profit? But, at the same time, developing countries--and the citizens who can barely pay for food, much less medication--can't afford to pay the prices demanded in mature markets. And what good is a lifesaving drug if only a tiny fraction of patients can use it?Not surprisingly, U.S. Commerce Secretary John Bryson came down on Big Pharma's side, The Economic Times reports. During a visit with Indian Commerce Minister Anand Sharma, Bryson protested the government's order that Bayer ($BAY) allow domestic drugmaker Natco Pharma to knock off its cancer drug Nexavar at a vastly reduced price.Bryson told Sharma that "(a)ny dilution of the international patent regime was a cause for deep concern for the U.S.," a government official told the ET. But Sharma countered, saying the World Health Organization's compulsory licensing provisions were established for cases just like this--life-threatening illness treated by a drug out of reach at brand-name prices.Meanwhile, India's Supreme Court is hearing arguments in Novartis' ($NVS) long-running patent dispute. The fight involves the Swiss drugmaker's groundbreaking cancer treatment Gleevec, which India's patent officials deemed unworthy of market exclusivity. The case not only determines the fate of Gleevec--and the patients who need it--but could affect access to HIV drugs and other treatments now produced and sold at low cost.If Novartis succeeds in striking down the Indian patent provision in question, "it will open a flood of patents," Leena Menghaney, a lawyer with Médecins Sans Frontières, told the Globe and Mail. And that could make many drugs suddenly inaccessible.But Novartis maintains that access to medicines depends on patent protection. The company "is seeking clarity on whether we can rely on patents in India and whether we as a research-based organization can continue to invest in the development of better medicines for India," Novartis' top official in India, Ranjit Shahani, told the newspaper. We'll soon see how the Indian justices feel.- see the ET story
- get more from The Globe and MailRelated Articles:
Indian government forces Bayer to accept generic Nexavar competition
Indian government defends country's generics industry
Natco wants OK to copy patented Pfizer HIV drug read more..

source:http://www.fiercepharma.com