Pharmaceutical

Pharmaceutical Regulatory Information

Effective drug regulation on the part of nations both promotes and protects the health of the public through ensuring several things. Medicines that are of adequate quality, are safe and efficient are required. Health care professionals and patients must have the needed information to enable them to use the medications rationally. Medicines must be manufactured, stored, distributed and dispensed in appropriate manners. Any illegal manufacture and trade of drugs must be both detected and adequately sanctioned. Promotion and advertising of drugs must be balanced, fair and aimed at the rational use of drugs. Access to medications must not be hindered by unjustified regulatory work.

National governments are held responsible for the establishment for strong national drug regulation authorities (DRA's) that have a clear mission, realistic objectives, a solid legal basis, an appropriate organizational structure, suitable financing, an appropriate level of qualified staff, equipment and information, access to technical literature, and the capacity to exert effective market control. DRA's are accountable to both the government and the public at large for their decisions and should be transparent. The DRA's evaluation and monitoring mechanisms need to be built into its regulatory system to assess attainment of its established objectives.

The Food and Drug Administration's (FDA) Mission Statement

"The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health."

For further information from the FDA, please visit: http://www.fda.gov/default.htm

Health Canada's Mission Statement

"Health Canada plays an active role in ensuring that you have access to safe and effective drugs and health products. The Department strives to maintain a balance between the potential health benefits and risks posed by all drugs and health products. Our highest priority in determining the balance is public safety. Working together with other levels of government, health care professionals, patient and consumer interest groups, research communities and manufacturers, our department endeavors to minimize the health risk factors to you and maximize the safety provided by the regulatory system for these products. We also strive to provide you with the information you need to make healthy choices and informed decisions about your health.

Health Canada is not a manufacturer or distributor of drugs and health products. We are the federal regulator. For additional drug information related to treatment options or where drugs or health products are sold, please contact your health professional or the individual company directly. Health Canada is committed to providing timely access to sound, evidence-based information. We want to ensure that Canadians remain up-to-date on current developments and issues pertaining to drugs and health products in Canada."

For further information about Health Canada, please visit: http://www.hc-sc.gc.ca/dhp-mps/index-eng.php

Medicines and Healthcare products Regulatory Agency - United Kingdom

"We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgments to ensure that the benefits to patients and the public justify the risks. The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgments to ensure that the benefits to patients and the public justify the risks.

We keep watch over medicines and devices, and we take any necessary action to protect the public promptly if there is a problem. We aim to make as much information as possible publicly available. We enable greater access to products, and the timely introduction of innovative treatments and technologies that benefit patients and the public. We encourage everyone - the public and healthcare professionals as well as industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action."

For further information about the Medicines and Healthcare products Regulatory Agency, please visit: http://www.mhra.gov.uk/index.htm

Further Information Regarding Pharmaceutical

FREE Drug Discount Card Raises Funds for Disabled Veterans
Disabled American Veterans (DAV) announces the launch of a free prescription drug discount card that offers savings up to 75% and when the card is used, 50 cents will be donated to the DAV from United Networks of America.

Epilepsy Drugs could Treat Alzheimer's and Parkinson's
Researchers in the USA have discovered a potential new function for anti-epileptic drugs in treating neurodegenerative disorders such as Alzheimer's and Parkinson's disease.

New Prolastin Version Approved by FDA
Talecris Biotherapeutics today received approval from the U.S. Food and Drug Administration for PROLASTIN-C (Alpha1-Proteinase Inhibitor [Human]), a more concentrated version of PROLASTIN produced using advances in manufacturing technology.

Bell's Palsy Study - Rethink of Cause and Treatment
Drugs widely prescribed to treat facial paralysis in Bell's palsy are ineffective and are based on false notions of the cause of the condition, according to Cochrane Researchers.

Post-stroke Upper Limb Spasticity - Phase III Data for NT 201
Data published in Clinical Neuropharmacology shows significant improvement in muscle tone and disability with NT 201

Blood Thinning Drug Safer than Rat Poison
With fewer side-effects and complications than warfarin, the reviewers see many potential benefits from dabigatran. According to Olshansky, it is "perhaps one of the important drug discoveries in the past decade.

OxyContin - Information Uses and Side Effects
OxyContin is in a group of drugs called narcotic pain relievers. It is similar to morphine. OxyContin tablets are used to treat moderate to severe pain. The extended-release form of this medication is for around-the-clock treatment of pain relief associated with injuries, bursitis, dislocations, fractures, neuralgia, arthritis, lower back pain, and pain associated with cancer.

FDA Approves Extavia for Multiple Sclerosis
The US Food and Drug Administration (FDA) has approved Extavia(R) (interferon beta-1b), the first in a new planned portfolio of multiple sclerosis (MS) medicines from Novartis to help patients manage this devastating disease.

Immunotec Announces Immunocal Clinical Research Initiative
Immunotec Inc. announced today that the Natural Health Products Directorate (NHPD) - a division of Health Canada responsible for evaluating the safety, efficacy and quality of natural health products (NHPs) - granted authorization for Immunotec to conduct a clinical trial of IMMUNOCAL(R) in elderly persons.

Electronic Smartpill Pill Measures pH Levels in Digestive Tract
An electronic diagnostic tool called the SmartPill is swallowed by patients in order to take measurements as it travels through the gastrointestinal tract.

Once-a-month Treatment for Postmenopausal Osteoporosis Approved in Canada
Health Canada has approved Actonel(R) (risedronate sodium tablets) 150 mg, Canada's first and only once-a-month dosing option in the treatment of postmenopausal osteoporosis. Canadian patients at high risk of osteoporotic fracture now have the convenience of taking one tablet on the same day each month.

Tamiflu for H1N1 Swine Flu Avian Flu and Influenza A - B
With increasing fears about the potential for a new swine flu pandemic, Tamiflu has received substantial media attention. Governments, corporations, and even some private individuals are stockpiling the drug. Production is currently sufficient to meet the demand only for seasonal influenza and for government stockpiling.

Gamunex Improves Quality of Life for CIDP Patients
CIDP is a debilitating nerve disease that results in progressive weakness in the arms and legs, causing significant disability for many individuals. Gamunex is the first and only FDA-approved product for the treatment of chronic inflammatory demyelinating polyneuropathy - CIDP.

New Heart Drug - World First
UK patients are the first to benefit from the launch of a new heart drug prasugrel (Efient), following authorisation by the European Medicines Agency (EMEA). The availability of prasugrel offers fresh hope to patients who have unstable angina or have had a heart attack - known as Acute Coronary Syndromes (ACS)(1) - who undergo a PCI procedure (angioplasty) to re-open a narrowed or blocked artery.

New Drug Shows promise for Psoriatic Arthritis
Psoriatic arthritis affects about 11 percent of patients with psoriasis. Anti-tumor necrosis factor agents, which block signaling molecules that induce inflammation, improve the symptoms of psoriatic arthritis.

Link Between Osteoporosis Drugs and Heart Problems
New research at Wake Forest University School of Medicine evaluated the link between a common class of drugs used to prevent bone fractures in osteoporosis patients and the development of irregular heartbeat.

Oxycodone Effective Against Shingles Pain
The painkiller oxycodone is effective at treating the acute pain of shingles, an illness that often causes severe pain which can become long-lasting and sometimes even permanent.

New Migraine Drug May Stop Pain with Fewer Side Effects
International research involving Mayo Clinic researchers may lead to new relief for migraine sufferers. The disabling headaches experienced by 30 million Americans, most of them women, are commonly treated with drugs when nonprescription analgesics don't help.

Dangerous Drug Reactions
Medical drugs are far from safe and there are often adverse reactions in the body associated with taking drugs. Adverse drug reactions are reactions that are unintended or undesired. If you take or intend to take medically prescribed drugs you need to be aware of the potential for these reactions in the body.

Antibiotics and Superbugs
Infections have always been with us and they have caused a lot of suffering and fear. In an attempt to deal with the bacteria which cause some infections medical science has developed antibiotics. The antibiotics were developed without consideration being given to the real underlying reasons why people were developing infections.

Canada Takes Steps to Improve Safety of Health Products
The Government of Canada has launched a new social marketing campaign encouraging Canadian consumers to use MedEffect Canada to report suspected side effects from health products and access the latest safety information.

Antibiotics That Don't Trigger Resistance
Bacterial resistance to antibiotics is one of medicine's most vexing challenges. In a study described in Nature Chemical Biology, researchers from Albert Einstein College of Medicine of Yeshiva University are developing a new generation of antibiotic compounds that do not provoke bacterial resistance.

Innappropriate Drug Prescriptions Wasting Millions, Raising Health Risks
A recent study in Oregon suggests that drugs designed for treating the most severe mental illnesses are often prescribed at inappropriately low doses and at considerable expense, for use in conditions where their benefit has not been established. In this case, prescription drugs that might cost as much as $20 to $25 a day were being widely used to treat problems for which they were not FDA-approved.