Regulations
When health goes Social: FDA pens proposal
The guidelines from US FDA would not necessarily carry any legal implications, but would rather serve as something that is suggested or recommended, though not required
 
The US Food and Drug Administration (FDA) has its concerns about Twitter; namely, how big pharma and others use the character-restricted platform to market its products. At the center of the issue is the challenge to communicate both the benefits and risks of a product – and other consumer information the FDA deems important – in a space limited to 140 characters. Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion, writes
In today’s world, in addition to traditional sources of medical product information, patients and health care providers regularly get information about FDA-regulated medical products through social media and other Internet sources… But, no matter the Internet source used, benefit claims in product promotions should be balanced with risk information.
 
To that point, the FDA has released a draft guidance on what the industry should be doing when it tweets, uses paid search engine results, or otherwise advertises prescription drugs or medical devices on the web where space is limited. The guidelines aren’t meant for product websites, individual product pages on social media, and online web banners where space isn’t limited. The document, which is in a feedback stage until 16th September, would not necessarily carry any legal implications, but would rather serve as something that is suggested or recommended, though not required.
 
As an example of what the FDA would consider acceptable on Twitter, the draft guidance offers up a sample tweet for a fictitious drug called NoFocus:
NoFocus (rememberine HCl) for mild to moderate memory loss-May cause seizures in patients with a seizure disorder www.nofocus.com/risk
 
The tweet works, according to the FDA, because it presents the most serious precaution associated with the drug alongside the prescribed treatment. It also contains a link to a full description of potential risks, and it includes the brand and generic name. Also, notice the dash between “loss” and “May.” The draft ordinance allows for the use of punctuation marks, common abbreviations and other symbols (like an ampersand in place of “and”) to help address character space constraints.
 
Of course, for drugs whose label details several potentially serious health risks – take Viagra, for example – the challenge to cram it all in a 140-word tweet becomes a difficult if not impossible task. The draft guidance suggests not to fight that fight:
If a firm concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character-space-limited communication, then the firm should reconsider using that platform for the intended promotional message.
 
TINA.org investigated further and searched for some live tweets that would potentially run afoul of the draft guidance. We found the following post on the Twitter page for Pfizer: 
It would seem that this tweet for an FDA-approved drug called Elelyso immediately comes up short of the draft guidance’s recommendations because it fails to disclose any potential health risks, and thus should not be posted to Twitter.
 
If you come across a tweet or paid search engine result (such as you’d find on Google or Yahoo) that you think may violate the FDA’s draft ordinance, tweet at TINA.org @TruthinAd, leave a message on our Facebook page, or alert us here
 

User

Abhishek, we will miss you terribly...

Our ever-smiling and hard-working colleague, Abhishek Rajak, who used to upload all the content and pictures on Moneylife.in, died in a tragic railway accident last night. We are grief-stricken  

It is with deep grief that we at Moneylife share with you the news, that our dear colleague, young Abhishek Rajak, died in an alleged railway accident last night. Like any other day, the bubbly youngster was on his way home. He was to have taken the 7.47pm Kalyan fast (15 coaches) local to reach Dombivali. He never made it.

When his father called at 10.30pm to check if he had been working late, we began to make frantic calls. Well known railway activist Samir Zaveri made calls to the railway helplines. He also asked a colleague to call the Government Railways Police (GRP) numbers at Dadar Station. At that time, he was told that Abhishek had been detained on suspicion but had been released. When Abhishek’s mother called the same number, she too was told that he had been detained and released 10 minutes ago. His mobile phone was still switched off.

After waiting for him to arrive at Dombivali station until 11.30pm, we began to worry again. Another round of calls started.  Our journalist friends also chipped in to help.

Rajendra Aklekar, Senior Assistant Editor of Mumbai Mirror, called several of his sources in the railway police. Varun Singh of Mid-Day met the GRP at Kalyan and also showed Abhishek’s photograph, which we had tweeted. Through all this, several of us were taking turns to call Abhishek’s number, just in case he switched it on again.

At 12.45pm came the deadly shock. Abhishek’s brother Amit again tried calling on his mobile. And this time, a police received the call and after making inquiry asked Amit to reach Diva station immediately. When Amit and his father reached Diva station, they saw the police loading a stretcher  in luggage compartment of a local train going towards Thane. Then Amit saw Abhishek lying dead on the stretcher.

We have lost a wonderful colleague, who was always smiling, hard working, every ready for challenges and on the threshold of life. Words cannot describe the loss we feel.

User

COMMENTS

Veeresh Malik

2 years ago

Latest response from Central Railways is that they know nothing about this vendor. They can not trace the vendor who was doing the recordings.

Veeresh Malik

2 years ago

Despite many attempts by Central Railways to wriggle out of providing a cogent response, we continue to follow-up here, and on one level are following up as per procedure with the Chairman, Railway Board as well as PMO on this case.

After one RTI Application was summarily dismissed, I went into First Appeal as well as escalated the issue, and have now received the full correspondence on the subject. In addition there has been some anonymous input also which shall be sent to the relevant authorities, since I am now trying to get the matter escalated beyond the present Central Railways/RPF.

This is the next series of questions I have asked.

+++

Vide response to PG filed online MORLY/E/2014/14616 and response No.G/190/PG/12/2014/RB-480 signed (S.M. Kelkar), Assistant Secretary (PG), General Managers Office, Central Railway, Mumbai CST 400 001 regarding Sonal Enterprises and CCTV at Dadar Central, please provide me with full information on-

1) Full details and addresses of Sonal Enterprises said to be maintaining CCTV at Dadar Central Railway Station on 17th April 2014, including names and addresses of proprietors or owners or Directors.

2) Full information on basis by which Sonal Enterprises were selected for this work at Dadar Central.

3) Full information on other locations under Central Railway where they have been selected in the past or now for any work from Indian Railways.

4) What are terms and condition of Sonal Enterprises contract with Central Railways or Indian Railways.

5) Under what tender or contract were Sonal Enterprises selected.

6) How many people do Sonal Enterprises employ.

7) What is EPFO registration number of Sonal Enterpris and amount paid in as per returns for FY 2013-2014.

8) What is ESI Registration number of Sonal Enteprise and amount paid in as per returns for FY 2013-2014.

9) What is Maharashtra State Professional Tax registration details of Sonal Enterprise and amount paid in as per returns for FY 2013-2014.

10) What is Service Tax registration and details of Sonal Enterprise and amount paid in as per returns for FY 2013-2014.

11) Where is the control room for the CCTVs set up by Sonal Enterprises for Dadar Railway Station.

Thank you.

Veeresh Malik

2 years ago

I am still following up on this despite bunch of evasive answers from CR in Mumbai. Have moved further enquiries with Railway Board in Delhi as well as the investigation authorities and hope to see some results. Meanwhile this has also happened.

http://www.moneylife.in/article/railways...

Veeresh Malik

3 years ago

To: Chairman, Railway Board,
New Delhi

Greetings and Jai Hind.

1) Please find enclosed response received from Office of General Manager, Central Railway, Mumbai.

2) This response is in direct contrast to actual events of 17th and 18th July 2014 as per media reports enclosed herein.

http://www.moneylife.in/article/abhishek...

http://www.moneylife.in/article/central-...

3) A "public grievance", as defined by our Prime Minister, is not a "representation". It is a grievance AGAINST a particular government agency. How that same agency within Government can respond to that very grievance, especially when it pertains to a crime resulting in death, is not understood.

By way of information, I am adding this response as well as my response to another set of Public Grievances currently filed also with other Government agencies. It is obvious that the Office of General Manager of Central Railways has not applied full effort, because nobody has contacted any of the people who actually were informed that Abhishek Rajak had been reportedly detained by Central Railway at Dadar prior to his death.

Sincerely,

Veeresh Malik

REPLY

Michael Mason-Mahon

In Reply to Veeresh Malik 3 years ago

I do wish you all the best in obtaining all the information. So that Abbishek's family.

Kind regards
Michael

Michael Mason-Mahon

In Reply to Veeresh Malik 3 years ago

I do wish you all the best in obtaining all the information. So that Abbishek's family.

Kind regards
Michael

Veeresh Malik

3 years ago


[email protected]
17:06 (9 minutes ago)

to me
No.G.190/PG/7/2014/RB-176

Dear Sir,

Your representation has been examined in detail by the concerned
department and it is to state that no person by name mentioned was
detained at PRF/Thane Dadar on 17.07.2014, also the CCTV on the particular
date were working and correctly positioned.

Further, enquires revealed that Dy.SS/Diva informed Government Railway
Police, Thane about an unknown male body lying near Diva station. Later
the diseased was identified and information was given to his parents about
accident. Shri Rajkumar Rajak father of the deceased Late Shri Abhishek
Rajak, has not mentioned any incident about detention of his son at Dadar.

This is for your information please.

Yours Sincerely,


(P.N. Ramachandran)
Assistant Secretary (PG)
General Manager’s Office
Central Railway
Mumbai CST – 400 001
Ph: 022 - 22754030, 22697115


+++

This is one official response I have received. Am pursuing through other avenues also.

Sucheta Dalal

3 years ago

Dear Friends

On behalf of all of us at Moneylife and Moneylife Foundation, please accept out thanks for your messages of condolence. We are really touched.

We are still trying to find out what really happened but without much success so far.

Many friends and colleagues are trying to help, including those from our safe rail group and our consulting editor Veeresh Malik from Delhi.

Let us all work towards making rail travel safer by participating in effort to make the system accountable!

Thank you once again for your kind messages and concern!

w regards

Sucheta Dalal

REPLY

Veeresh Malik

In Reply to Sucheta Dalal 3 years ago

If anybody gets a phone call from any agency claiming to be investigating this death then please -

1) Convince yourself about the said agency by asking for a landline number and name as well as number of the senior person in that office.

2) Making a call back to that number to establish the genuineness of the person.

3) Responding that all information is as per the article already given and nothing more to add.

I received a call from 9004449817 and am not able to get more information on who and why was calling me.

Thanks / Veeresh

Nagesh Kini

In Reply to Sucheta Dalal 3 years ago

WE MUST NOT REST TILL WE GET JUSTICE DONE.

chan

3 years ago

I have been receiving some emails by his name giving details of moneylife programmes. May his soul rest in peace. Moneylife team should investigate the reasons of his untimely death.

Shubhankar Bhardwaj

3 years ago

Deeply saddened by this terrible news.

Heartfelt condolences to the family and loved ones of Abhishek.

Their can never be a pain greater than losing a young son. May the almighty give strength to the parents to cope up with this terrible loss...

Veeresh Malik

3 years ago

Please also see related article on this issue and PGs filed by me there, and it will be helpful especially if non-Mumbai people can file paralel/pincer PGs by copy-pasting same.

http://www.moneylife.in/article/central-...

Viswanathan

3 years ago

It is tragic that a young life is extinguished suddenly. The guilty must be punished

Nagesh Kini

3 years ago

From what little I know of Abishek, the entire tragedy smells extremely fishy and there's certainly more than meets the eye and this has be followed up vigorously to get to the bottom of the truth to ensure such instances are never repeated.
1. Why was he 'detained' at all? He was so puny and simple looking that there is no reason for anyone whatsoever to raise an iota of suspicion.
2.I doubt whether the grounds for detention are recorded at all. This has to be looked into.
3. Surely he'd have carried his MoneyLife ID card.

Harwant

3 years ago

I feel very sad to hear of the untimely loss of a young and brilliant son of India.

You would always live in our memories.

It is not at all clear as to what happened! The death must be investigated and action taken.

shadi katyal

3 years ago

I will request Money life to pursue the issue and find out what happened and why? You as a daily news magazine has more power than the poor parents who will be led from pole to pillar. We all feel that truth should come out and will give peace to the family.

Ravi Chopra

3 years ago

Distressed and angry to hear about the untimely and senseless death of your young colleague. Must bring the guilty to book.

Jayesh Jethalal Bhadasia

3 years ago

Am too very sorry after knowing about his tragic death.

Sensex, Nifty may struggle to move higher – Thursday closing report
Keeping themselves above Wednesday’s low, the Indian indices moved mostly in a range throughout the session on Thursday. Positive data from the US also helped to keep the momentum going.
 
S&P BSE Sensex opened at 25,541 while the NSE's CNX Nifty opened at 7,613, which was also its intra-day low. Sensex hit a low of 25,494. From the lows, the benchmarks reached up to 25,613 and 7,656. After hitting their respective highs, the indices tried keeping themselves higher. During this period, the indices witnessed volatile moves.
 
Sensex closed at 25,561 (up 11 points or 0.04%) while Nifty closed at 7,640 (up 16 points or 0.21%). The NSE recorded a volume of 89.87 crore shares. India VIX rose 1.60% to close at 14.9650.
 
Except for Realty (0.59%), Finance (0.17%) and Auto (0.11%) all the other Asian indices closed in the green. The top five gainers were Metal (2.49%), Commodities (1.69%), Nifty Midcap 50 (1.56%), Infra (1.50%) and Smallcap (1.49%).
 
Of the 50 stocks on the Nifty, 31 ended in the green. The top five gainers were Tata Power (3.72%), Grasim (3.27%), Kotak Mahindra Bank (3.18%), ACC (3.06%) and Hindalco (3.02%). The top five losers were M&M (3.28%), IDFC (2.48%), Bajaj Auto (2.34%), DLF (1.66%) and ONGC (1.20%).
 
Of the 1,598 companies on the NSE, 1,032 companies closed in the green, 500 companies closed in the red while 66 companies closed flat.
 
With the monsoon covering the entire country, though delayed, it is 15% below average in the past week, which is better as compared to the earlier weeks where it was around 40% below average.
 
Achieving the budgetary target of Rs 6.24 lakh crore in indirect tax collection during the current fiscal will be a challenge, a senior Finance Ministry official said today. The amount budgeted Rs6.24 lakh crore from indirect tax collection in 2014-15 is around 25% higher than the indirect tax mop-up (revised estimates) last fiscal.
 
With the positive move in the budget by raising export duty on bauxite companies like Hindalco may be benefitted by this move. Hindalco hit its 52-week high today and was the top gainer (3.91%) in the Sensex 30-pack.
 
Mahindra & Mahindra (3.18%), top loser in the ‘A’ group on the BSE and the top loser in the Sensex 30 stock, traded ex-dividend today. The company filed its shareholding pattern for June 2014 quarter on Wednesday, which saw an increase in the FII holding from 36.92% in March 2014 quarter to 39.24% in June 2014 quarter, while DIIs holding fell marginally from 15.88% to 15.52%. 
 
Crompton Greaves (up 13.45%) was the top gainer in the ‘A’ group on the BSE. Its board of directors at its annual strategic review meeting proposed to demerge its consumer products business unit into a separate listed company. The board believes that such a demerger will create better growth opportunities for its two large but significantly different businesses - power, industrial and automation which are B2B business, and the consumer products business which is B2C. The board has constituted a committee of directors to examine all relevant aspects of the process of demerger and listing and make suitable recommendations to the board.
 
US indices closed Wednesday in the positive. The Federal Reserve said in its Beige Book business survey released on Wednesday, 16 July 2014 that economic growth was modest to moderate in the latest period as all 12 of its districts reported stronger consumer spending and expanded manufacturing.
 
Except for Straits Times (0.07%) and Seoul Composite (0.37%) all the other Asian indices closed in the negative. Jakarta Composite (0.84%) was the top loser.
 
European indices were in the red and US Futures too were trading lower on the news that Housing starts fell to a nine-month low in June, and US and European Union imposed sanctions on Russian banks, energy companies and defense firms in the latest attempt to pressure the country to end support for Ukranian rebels.
 

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