Drug Information Bulletin

Bengal Branch Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com Web Site: http://www.ipabengal.org Contact: 09830136291

Drug Information Centre (DIC) Indian Pharmaceutical Association

Volume: 06

Number: 07
Content

27th May 2012

Standard Treatment Guidelines (STG) for Primary Healthcare Facilities published by SIGN, Ranchi, India in collaboration with CDMU, Kolkata, India and supported by EPN US FDA has given clarifications on successful implementation of Q8, Q9 and Q10 guidelines through Q & A FDA guidance on DTC TV ads is unconstitutional? Long-Acting contraceptives found 20 times more effective than other methods Medtronic Cuts 1000 Jobs Pharma companies unresponsive to overcharging notices Fake, Substandard Malaria drugs threaten efforts to fight disease US FDA has given clarifications on successful implementation of Q8, Q9 and Q10 guidelines through Q & A Since the Q8, Q9, and Q10 guidance were made final, experiences implementing the guidances in the ICH regions have given rise to requests for clarification. This question and answer (Q&A) document is intended to clarify key issues. The guidance reflects the current working procedure of the ICH Quality Implementation Working Group (Q-IWG) for implementing the Q8, Q9, and Q10 guidances. This guidance is a revision of the ICH guidance titled Q8, Q9, and Q10 Questions and Answers (May 2010). In November 2010, the May 2010 guidance was revised to add Q&A9 to section II.B.1 Design Space (2.1).

Standard Treatment Guidelines (STG) for Primary Healthcare Facilities published by SIGN, Ranchi, India in collaboration with CDMU, Kolkata, India and supported by EPN

2 The benefits of harmonizing technical requirements across the ICH regions can be realized only if the various quality ICH guidances are implemented and interpreted in a consistent way across the three regions. The Q-IWG is tasked to develop Q &As to facilitate implementation of existing quality guidance. http://www.fda.gov/downloads/Drugs/Guidanc eComplianceRegulatoryInformation/Guidances /UCM210822.pdf FDA guidance on DTC TV ads is unconstitutional? Two months ago, the FDA issued a draft guidance that stipulates when drug makers must submit their direct-to-consumer TV ads for agency review. These include initial ads for any prescription drug, or for a new or expanded indication; all TV ads for drugs that are subject to a Risk Evaluation and Mitigation Strategy; all TV ads for Schedule II controlled substances, and the first TV ad following a safety labeling update or an enforcement letter, among other things (here is the draft guidance). These categories reflect a risk-based approach that will enable the Agency to leverage its limited resources to best protect the public health by ensuring that certain high risk and high impact TV ads accurately and effectively communicate key information about advertised products, including their major risks and indications, the FDA wrote in its March draft guidance. Drug makers are not happy, though. Sanofi, for instance, complained to the FDA that submitting TV ads prior to airing could be very costly if the FDA requires revisions and, as a result, may prohibit DTC TV ads from running. Since then, the PhRMA trade group wrote a letter of its own to charge that a mandatory requirement that TV ads be reviewed prior to broadcast is overly broad and, therefore, unconstitutional. In its letter, PhRMA complains that the mandatory nature amounts to prior restraint of valuable, constitutionally protected commercial speech. Instead of a draft guidance that would implement regulations, PhRMA wants the FDA to pursue notice and comment rulemaking in a tailored, risk-based approach that conforms with the Supreme Courts directive that the First Amendment mandates that speech restrictions be narrowly drawn. PhRMA also maintains the FDA has not offered empirical evidence to support its position and, meanwhile, argues that the agency has issued only four warning or socalled untitled letters since 2008 that alleged any regulatory violations stemming from DTC TV ads, even though hundreds (perhaps thousands) of ads have aired since then. At the same time, PhRMA questions whether the agency can handle the workload the FDA estimates 82 ads may require review annually, which will be decided on a case-by-case basis and argues that delays may dissuade drug makers from creating ads, which may rob patients of needed health information. In order to address these concerns in a manner consistent with the Supreme Courts First Amendment jurisprudence, the trade group writes, PhRMA recommends that FDA reconsider the proposed broad scope of the DTC Review Program and narrowly target those advertisements where it can provide justification supported by empirical evidence to support a legitimate need for a pre-dissemination review and delay of commercial speech and the absence of other less restrictive alternatives,

3 Long-Acting contraceptives found 20 times more effective than other methods The Wall Street Journal reports on a study of about 7,500 women published in the New England Journal of Medicine finding that long-acting reversible contraception methods have a lower rate of failure than do other commonly prescribed contraceptive methods. Indeed, the study found that the long-acting contraceptives have failure rates below one percent while failure rates of other methods range from 4.8% to 9.4% over the three year study. The Los Angeles Times reports in its "Booster Shots" blog, "Health experts estimate that half of all pregnancies in the US are unintended." In the study, "researchers tallied 334 unintended pregnancies," and "156 resulted from birth control failures." Overall, "the pregnancy rate among women using pills, rings or patches was 4.8%" in the first year and 9.4% over three years. "Only 0.3% of women using IUDs or implants got pregnant after one year in the study, and only 0.9% got pregnant after three years," and the rates for "women who got hormone injections" were 0.1% and 0.7%. "After taking the women's age, educational background and number of prior accidental pregnancies into account, the researchers calculated that the risk of unintended pregnancy was almost 22 times higher with pills, patches and rings than with long-term birth control methods." Medtronic Cuts 1000 Jobs May 22--Fridley-based Medtronic is eliminating about 1,000 jobs, a total that includes about 220 positions in its Mounds View-based division for heart-rhythm devices. Medtronic officials disclosed the 1,000-job figure on Tuesday, May 22, as part of the medical device company's release of fourth-quarter financial results. The company previously confirmed the 220 job cuts in Mounds View. It was unclear exactly where the remaining 780 or so job cuts would be focused. "We are eliminating about 1,000 positions around the company and around the globe," said Gary Ellis, the company's chief financial officer, in an interview Tuesday. "It's kind of the normal, ongoing thing that goes forward as we shift resources from slower-growing markets to faster-growing markets." "Most of the employees that are affected have been communicated with," Ellis added. During the company's fourth quarter, which ended in late April, Medtronic took a charge related to the restructuring. Overall, the company reported fourthquarter earnings per share that beat analyst expectations by a penny; revenue of $4.297 billion also exceeded estimates from analysts surveyed by Thomson Reuters. Still, Medtronic continues to struggle with sluggish sales in its two largest product areas: heart rhythm devices, such as pacemakers and implantable defibrillators, and devices used in spine surgery.
Source: 1000-jobs http://www.qmed.com/news/medtronic-cuts-

Pharma companies unresponsive to overcharging notices Not even one of the 500-odd pharma companies has responded to the drug overcharging notices sent by the Department of Pharmaceuticals. This leaves the government with an enormous task of calculating the penalty for each

company, which can run up to Rs. 4,000 crore collectively. In February, the Department of Pharmaceuticals had sent notices to the companies through the Indian Drug Manufacturers' Association (IDMA), the industry body of Indian companies, and the Organisation of Pharmaceutical Producers of India (OPPI) that represents global pharma companies in India to furnish the overcharged amount as per their estimates. If the companies did not do so within a month, the department said it will fix the overcharged amount based on "whatever data becomes available to the government from whatever source." "We are examining options (to fix the amount)," Raja Sekhar Vundru, joint secretary of Department of Pharmaceuticals, told this reporter without elaborating how it would work out the amount. The dispute dates back to overcharging by the companies between April 1979 and August 1987. Last December, the Bombay High Court ruled in favour of the government allowing the Department of Pharmaceuticals to recover the amount from the companies ending the 16-year-old case. According to the government lawyer, the collective amount would run into as much as Rs. 4,000 crore, including interests. However, IDMA estimates the amount to be between Rs. 1,000 crore and Rs. 1,500 crore, excluding interests. According to a senior pharma industry executive, it would be a big exercise for the Department of Pharmaceuticals to calculate the fine as it has to first determine the cost of production for each

4 company at that time, based on the then bulk drug price and compare it with the retail price to arrive at the overcharged amount. At that time, government used to fix MRP of medicines made using 345 bulk drugs. Companies had argued that the notice was untenable because it was issued in 1996, much later after the Drug Price Control Order, 1979, was repealed by subsequent drug pricing orders. They also said they do not maintain such old data sought by the government.
Source: Economic Times

Fake, Substandard Malaria drugs threaten efforts to fight disease The New York Times reports that according to a study sponsored by the National Institutes of Health and published in The Lancet Infectious Diseases, "fake and substandard malaria drugs are a growing threat to efforts to beat back the disease." NIH scientists "analyzed 27 sets of tests of antimalaria drugs purchased in Southeast Asia and Africa between 1999 and 2010," finding that "about a third of the drug samples from both continents failed." Reuters quotes Gaurvika Nayyar of the Fogarty International Center at the US National Institutes of Health, who said, "Despite a dramatic rise in reports of poorquality anti- malarial drugs over the past decade, the issue is much greater than it seems. Most cases are probably unreported, reported to the wrong agencies, or kept confidential by pharmaceutical companies."

Subscribe Subscribe//Unsubscribe: Unsubscribe: ipabengal.dic@gmail.com ipabengal.dic@gmail.com