rna - regulatory news alert (volume 2 issue 6) september 2014
TRANSCRIPT
VOLUME 2 | ISSUE 6
SEPTEMBER 2014
PANEL OF EDITORS
Dr. H. G. ShivakumarDr. T. M. Pramod KumarDr. Balamuralidhara V.
Dr. M. P. VenkateshDr. Valluru Ravi
Ms. Shilpi Khattri
TECHNICAL EDITOR
Akshay Anand M.
NEW YORK LEGALIZES MARIJUANA; BERKELEY OFFERS IT FOR FREEMarijuana to treat PTSD (Post Traumatic Stress Disorder) in Arizona
There are currently ten state-licensed medical marijuana dispensaries in Phoenix, AZ. Arizona passed its Medical Marijuana Act in 2010 to allow people with specific debilitating conditions such as cancer, chronic pain and muscle spasms to use medical marijuana. Last month, the state's Department of Health Services Director, Will Humble, decided to allow people with post-traumatic stress disorder (PTSD) to use medical marijuana as a form of palliative care, though not as a primary treatment for the condition.
FDA WARNS CONSUMERS ABOUT FRAUDULENT EBOLA DRUGSThe U.S. Food and Drug Administration is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus. Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection. There are currently no FDA-approved vaccines or drugs to prevent or treat Ebola. Although there are experimental Ebola vaccines and treatments under development, these investigational products are in the early stages of product development, have not yet been fully tested for safety or effectiveness, and the supply is very limited. There are no approved vaccines, drugs, or investigational products specifically for Ebola available for purchase on the Internet. By law, dietary supplements cannot claim to prevent or cure disease. Individuals promoting these unapproved and fraudulent
products must take immediate action to correct or remove these claims or face potential FDA action. It is important to note that according to the Centers for Disease Control and Prevention (CDC), Ebola does not pose a significant risk to the U.S. public. Unfortunately, during outbreak situations, fraudulent products that claim to prevent, treat, or cure a disease all too often appear on the market. The FDA monitors for these fraudulent products and false claims and takes appropriate action to protect consumers. Ebola is the
cause of a viral hemorrhagic fever disease. Symptoms include fever, headache, joint and muscle aches, weakness, diarrhea, vomiting, stomach pain, lack of appetite, and abnormal bleeding. Symptoms of the virus can appear anywhere from two to 21 days after exposure, but is most commonly seen on days eight to 10. n the United States, Ebola is not a water-borne or food-borne illness and is not transmitted through the air. Ebola is spread through direct contact with the body fluids of an infected person, or with objects like needles that have been contaminated with the virus. People who do not show symptoms are not contagious. Consumers who have seen these fraudulent products or false claims are encouraged to report them to the FDA.
ANNIVERSARY
1 NR A
F D A A P P R O V E S TIVICAY; A NEW DRUG T O T R E A T H I VEMA TO STIMULATE BETTER USE OF GENOMIC DATA AND BIOMARKERS IN MEDICINES DEVELOPMENT AND SAFETY M O N I T O R I N G
PFIZER SUBMITS NDA FOR PALBOCICLIB B R E A S T C A N C E R TREATMENT DRUG
‘ M A D E I N I N D I A’ THRUST TO FUEL API S E C TO R G R OW T H
NATIONAL PHARMACEUTICAL PRICING AUTHORITY TO SET UP PRICE MODULATING CELLS WITHIN STATE DRUG CONTROL D E P A R T M E N T S
AHA: E-CIGARETTES SHOULD BE SUBJECT TO S T R I C T F E D E R A L R E G U L A T I O N
AHA ‘FIERCELY COMMITTED’ TO PREVENT TOBACCO ADDICTION IN ANOTHER G E N E R A T I O N
jsspharma.org
COLLEGE OF PHARMACYSS NAGARA, MYSORE
FDA APPROVES ; A NEW DRUG TO TREAT HIVTIVICAYThe U.S. Food and Drug Administration has approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection. Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. It is a pill taken daily in combination with other antiretroviral drugs. Tivicay is approved for use in a broad population of HIV-infected patients. It can be used to treat HIV-infected adults who have never taken HIV therapy (treatment-naïve) and HIV- infected adults who have previously taken HIV therapy (treatment-experienced), including those who have been treated with other integrase strand transfer inhibitors. Tivicay is also approved for children ages 12 years and older weighing at least 40 kilograms (kg) who are t reatment-naïve or treatment-experienced but have not previously taken other integrase strand transfer inhibitors. "HIV-infected individuals require treatment regimens personalized to fit their condition and their needs," said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. "The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA." About 50,000 Americans become infected with HIV each year and about 15,500 died from the disease in 2010, according to the Centers for Disease Control and Prevention. Tivicay's safety and efficacy in adults was evaluated in 2,539 participants enrolled in four clinical trials. Depending on the trial, participants were randomly assigned to receive Tivicay or Isentress (raltegravir), each in combination with other antiretroviral drugs, or Atripla, a fixed-dose combination of efavirenz, emtricitabine and tenofovir. Results showed Tivicay-containing regimens were effective in reducing viral loads. A fifth trial established the pharmacokinetics, safety and activity of Tivicay as part of treatment regimens for HIV-infected children ages 12 years and older weighing at least 40 kg who have not previously taken integrase strand transfer inhibitors. Common side effects observed during clinical studies include difficulty sleeping (insomnia) and headache. Serious side effects include hypersensitivity reactions and abnormal liver function in participants co-infected with hepatitis B and/or C. The Tivicay label gives advice on how to monitor patients for the serious side effects. Tivicay is marketed by ViiV Healthcare and manufactured by GlaxoSmithKline, both based in Research Triangle Park, N.C. Isentress is marketed by Whitehouse Station, N.J.-based Merck, and Atripla is marketed by San Francisco, Calif.-based Gilead.
ANNIVERSARY
VOLUME 2 | ISSUE 6
SEPTEMBER 2014
EMA TO STIMULATE BETTER USE OF GENOMIC DATA AND BIOMARKERS
IN MEDICINES DEVELOPMENT AND SAFETY MONITORINGThe European Medicines Agency (EMA) has released a draft concept paper in August for public consultation outlining the key elements that will be developed in a guideline on good genomics biomarker practices. Recognising the importance of genomics in the development of innovative, targeted treatments and to inform the best use of medicines, the concept paper proposes a framework for the generation and assessment of robust genomic data. With this guidance the EMA aims to enhance transparency, consistency, reproducibility and cross-validation between genomic-driven studies. This is expected to promote and facilitate the use of genomic data for the development of so-called personalised medicines (a medical approach which is tailored to a patient or group of patients), the safety monitoring of medicines and the early diagnosis of disease. Due to genetic variability, not all people respond in the same way to the same medicines. The development of new technologies allows new knowledge to be generated on how a person's genetic makeup influences his or her response to certain medicines, both in terms of efficacy and safety. Genomic data have become increasingly important during the evaluation of a medicine's benefits and risks as well as in post-authorisation safety monitoring to inform the best use of medicines.Guidance on good genomic practices will maximize the information gathered from genomic studies and facilitate the implementation of pharmacogenomics in drug development and patient treatment to the benefit of all stakeholders.
Pfizer has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for palbociclib to treat postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) a d v a n c e d breast cancer who have not r e c e i v e d p r e v i o u s s y s t e m i c treatment for their advanced disease. The NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment these women. The filing is based on the final results of PALOMA-1, a randomized, Phase II trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients. The company received breakthrough therapy status from the FDA for Palbociclib in April 2013, to treat first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. Pfizer Oncology president Garry Nicholson said, “Today's submission marks an important milestone for Pfizer and palbociclib, and a potential advance for women with advanced breast cancer."
PFIZER SUBMITS NDA FOR PALBOCICLIB N E W D R U G F O R B R E A S T C A N C E R T R E A T M E N T
‘MADE IN INDIA’ THRUST TO FUEL API SECTOR GROWTH Union government’s ‘Made in India’ emphasis could notch up the growth prospects for the Indian active pharmaceutical ingredient (API) manufacturers. It would also reduce the dependence on China for a range of excipients and intermediates, said Anjan K Roy, managing director, RL Fine Chem and member Karnataka Drugs and Pharmaceutical Manufacturers Association. The API industry would see a further boost in terms of developing a strong product pipeline with the arrival of poly pills. There are several Indian API players engaged in advanced research of the active ingredients used to produce a combined tablet for blood pressure and cardiovascular disease. But since these companies are in the process of applying for patents, no details can be disclosed, he added. However, what is e n c o u r a g i n g i s t h e n e w government’s efforts to take the right steps to encourage the domestic API, intermediate and excipients manufacturers and this is a positive move as much of these products are imported from China, Roy told Pharmabiz. Indian API industry will be on a high growth trajectory by 2020 with the new government looking to encourage domestic manufacturing with a slew of benefits. This will see the sector augment its international presence. So long, all efforts were to allow China dominate in this space and Indian API sector was losing its ground. But now we see a turnaround as the sector is being recognised, he said. In the case of drug registration fees, the earlier government has maintained the skewed levy. For instance China could register in India for a $2,000 per drug. But India could register each drug at $20,000. Now the Union government is moving to increase the levy for the products from China. China under the President Xi Jinping is looking to make its economy more dynamic by opening more industries to foreign competition. There are drugs like paracetamol and antibiotics where China has a clear edge. In the case of India, it is gaining ground to prove its expertise in oncology and neuropsychiatry APIs. Further, there is also a big opportunity for Indian APIs to manufacture Angiotensin II receptor antagonists or sartans used in drugs for hypertension, diabetic nephropathy and congestive heart failure. Some of the APIs are osartan, candesartan, irbesartan, telmisartan, olmesartan, valsartan and eprosartan . India also has the expertise in dermatology and dental APIs. Therefore by 2020, Indian API industry could compete with China head on and be a preferred partner for global players in the space, Roy said.
ANNIVERSARY
3 NR A
PHARMABIZ.COM
NATIONAL PHARMACEUTICAL PRICING AUTHORITY TO SET UP
To strengthen its network and make the monitoring of the drug prices better, the National Pharmaceutical Pricing Authority (NPPA) has finally decided to go ahead with its plan to set up price modulating cell in each of the state drug control departments. To deliberate on this matter the NPPA recently had a meeting with all the state drug controllers in Delhi. It is understood that as per the proposal, the NPPA plans to set up a dedicated cell within the office of each of the state drug departments. While the expenditure related to manpower, amenities and other infrastructural cost will be borne by the NPPA, state government will have to provide the space for setting up the office within the state drug regulatory office. Under the proposed scheme, the cell is to be headed by one person along with a team of NPPA officials whose strength will vary as per the size of the pharma industry in respective states. A highly placed source informs that the NPPA has categorised the states based on three categories, i.e. based on maximum, minimum and least number of pharma cos in the state for better division of work. They will be responsible to closely work with the state drug regulators to find out any discrepancies that a f fect the consumers. The officials heading the cell will be required to report their findings to the NPPA directly in case they find any pharma cos violating the law by selling the drugs above the ceiling price. According to a highly placed source, the NPPA plans to go ahead with this project on a phased manner and hopes to get the required clearance from the centre at the earliest.
PRICE MODULATING CELLS WITHIN STATE DRUG CONTROL DEPARTMENTS
Prime Minister Sri Narendra Modi during his Speech on the Independence Day Celebrtions
VOLUME 2 | ISSUE 6
SEPTEMBER 2014
jsspharma.org
AHA: E-CIGARETTES SHOULD BE SUBJECTED TO STRICT FEDERAL REGULATION
The statement, recently published in the journal Circulation, also calls for strict regulations on marketing of e-cigarettes and a ban on flavored vapors amid concerns that they make the devices appealing to youngsters. E-cigarettes (electronic cigarettes) are battery-operated devices whereby the user inhales flavored, vaporized nicotine solutions, although there are some solutions available that do not contain nicotine. There has been much controversy surrounding the use of e-cigarettes recently. Earlier this year, Medical News Today reported on a study by researchers from University College London in the UK claiming that e-cigarettes help smokers to quit. But other research challenged this theory. A study published in JAMA Internal Medicine suggested there is no association between e-cigarette use and reduced cigaret te consumpt ion , there fo re e- cigarettes should not be marketed as smoking cessation aids. In fact, another study published in JAMA Pediatr ics c la imed that e- c iga re t t e s may encourage conventional cigarette use in adolescents. It found that e-cigarette use among middle and high school students doubled between 2011 and 2012, and that 76.3% of these youths also smoked conventional cigarettes. This study and others reporting similar findings have been the basis for the new recommendations issued by the American Heart Association (AHA).
ANNIVERSARY
NR A
Due to concerns that e-cigarette use among youths could lead to nicotine addiction and encourage use of conventional tobacco products, the American Heart Association have issued new recommendations stating that e-cigarettes should be subject to a federal ban for minors.
4
The AHA have issued a new policy statement urging e-cigarettes to be subject to strict regulations, including a federal ban on the
sale of the devices to minors.
AHA ‘FIERCELY COMMITTED’ TO PREVENT TOBACCO ADDICTION IN ANOTHER GENERATION Nancy Brown, CEO of the AHA, notes that over the last 50 years, 20 million Americans have died of tobacco-related causes. As a result, she stresses that the AHA are "fiercely committed" to preventing the tobacco industry from addicting another generation to their products, adding: "Recent studies raise concerns that e-cigarettes may be a gateway to traditional tobacco products for the nation's youth, and could renormalize smoking in our society. These disturbing developments have helped convince the association that e-cigarettes need to be strongly regulated, thoroughly researched and closely monitored." In April this year, the Food and Drug Administration (FDA) announced a proposal to extend current tobacco regulation to include e-cigarettes. If the rule is made final, it may mean that minors under the age of 18 will not be able to purchase e-cigarettes. The devices may also need to include health warnings, and although manufacturers will not be banned from marketing them, the products may need to be subject to FDA review prior to advertisement. The public comment period for this proposal ceased last month, and the FDA are now in the process of making any changes. But in June, the AHA and other organizations said the FDA need to move faster and do more. They said the organization should issue a "complete, effective final rule with no exceptions and address critically important issues not addressed in the proposed rule, such as marketing and flavorings that appeal to kids." The AHA have echoed this in their latest recommendations, noting that e-cigarette advertisements using celebrities and marketing of "alluring" flavors make the products more appealing to children and adolescents. They point to a recent study revealing that youth exposure to e-cigarette advertisements soared by 250% between 2011 and 2013, meaning 24 million youngsters are now exposed to such marketing. "In the years since the FDA first announced it would assert its authority over e-cigarettes the market for these products has grown dramatically," says Brown. "We fear that any additional delay of these new regulations will have real, continuing public health consequences. Hence, we urge the agency to release the tobacco deeming rule by the end of this year."
NR AR E G U L A T O R Y N E W S A L E R T
N E W S L E T T E R P U B L I S H E D B YPHARMACEUTICAL REGULATORY AFFAIRS GROUPD E P A R T M E N T O F P H A R M A C E U T I C SJSS UNIVERSITY COLLEGE OF PHARMACYM Y S O R E , K A R N A T A K A - 5 7 0 0 1 5 CONTRIBUTORS: AKSHAY ANAND, AVDHESH KUMAR, GAYATHRI RAJU, KARTHIK, KAUSHIK, KIROSHKAR, NAGA VAMSI, NITESH MATADA,R AV I S H A N K A R , SA L LY N E E H A R I K A , SA N D E E P K U M A R , SPANDITA GHOSH, SURAJ PAMADI, TEJASWI ALEKYA, VINOD RAJ
PAGE LAYOUT AND DESIGN BY AKSHAY ANAND SC
AN
TH
E Q
R C
OD
E T
O R
EA
D O
NL
INE
VOLUME 2 | ISSUE 6
SEPTEMBER 2014