Draft Legislation for FDA inspections:

Draft legislation has been put forward which would require the US Food and Drug Administration (FDA) to inspect foreign manufacturing plants every four years. The Food and Drug Administration Globalisation Act of 2008 is based around four existing bills and has come to prominence as a result of the turbulent times recently faced by the FDA, including the heparin contamination case, which has been linked to 62 deaths, as well as concerns over the safety of imported ingredients such as glycerin.Until an inspection is carried out any drug, active pharmaceutical ingredient, class II or III device or device component may not be sold interstate. This covers anything manufactured, prepared, propagated, compounded or processed at the site.To enforce the monitoring of foreign plants the bill proposes the creation of a permanent foreign inspection force, with staff assigned to specific countries. This way they would gain an understanding of the companies, language and culture, leaving them better prepared to perform their duties.Some of the funding required to support the initiative will come from an annual registration fee to be paid by drug and device manufacturers, the amount of which will be determined by the Secretary.The implementation of this is proposed to take place at the start of the 2009 fiscal year. In addition drug labels and medical devices would have to state the source of the active ingredient or the nation in which the device was manufactured. Those behind the legislation feel that consumers have the right to know where their purchases come from.Speaking about the legislation Senator Dingell said: "For example, if it comes from Great Britain, you're going to assume it's pretty safe. If it comes from Canada, it's probably pretty safe. If it comes from China, you're going to say, 'Holy cats, we better watch out.'"The Pharmaceutical Research and Manufacturers of America (PhRMA) has not taken a stance on the inspections or labeling but has weighed into the debate over the FDA's funding.Ken Johnson, senior vice president PhRMA said: "The agency's responsibilities have soared, yet its resources have not kept up to meet these increasing demands." The senate had sought a 20 per cent increase to the FDA's funding but President Bush's budget only granted a 3 per cent rise to the agency.There are aspects of the draft legislation that the Bush administration had wanted to be brought into statute, including a reduction in the FDA's powers to recall products. Under this legislation the FDA would merely be able to request companies undertake a recall, whereas it can currently force a recall.The first hearing of the draft is due to take place on April 24, with others expected to follow.
Dr.Vikram.KSource: Fierce Pharma

DIA in India.

DIA has announced the recent opening of its first office in India, in Mumbai, along with the creation of a Provisional Advisory Council of India (ACI).

The "rapid growth" of India's biopharmaceutical industry, which is predicted to reach $1bn by 2010 up from $100m in 2006, was behind the DIA's decision to establish a presence in the country."The statistics are incredible… More than 15 per cent of the world's clinical trials are expected to be conducted in India by 2011", said Linda McGoldrick, DIA's worldwide executive director."The industry's meteoric rise in this emerging region creates a significant need for DIA's credible international forum that is precedent-setting. We bring together industry, academia, regulators and patient organisations to provide ongoing training for professionals on regulations, clinical practices and safety standards that will impact the approval of drugs developed in India for the global market." The DIA's Indian office is the fourth global location for the association, which also operates from Pennsylvania, US, Basel, Switzerland, and Tokyo, Japan.In conjunction with the new office, the provisional ACI has been established to assist in the early planning stages of DIA initiatives in India and advise on the region's educational needs for training programs and conferences.Chaired by Dr Nandkumar K. Chodankar, president of the API Division of Watson Pharmaceuticals, the ACI is comprised of 13 members who represent industry, academia, and government agencies.Ron Fitzmartin, president of the DIA's Board of Directors said that the agency's "comprehensive outreach" to the Indian marketplace is "a natural one" for DIA. "The interest in this region is global…So many of our existing North American, European, and Japanese members are looking at India as an important region in drug development," he said. "Our presence there means we can help our membership around the globe understand the evolving Indian pharmaceutical landscape while also providing impartial training forums and multidisciplinary perspectives for the growing number of Indian drug development professionals."As a first step, the DIA is launching its first annual Indian regulatory conference, to be held next week on April 28-29 in Mumbai, which will address the issues surrounding the quality and safety of clinical trials in the country. Over the past two years, the agency has already started running conferences on drug discovery and clinical development in India, pertaining to the global development of biopharma products.
Dr.Vikram.K
Source: Fierce Pharma

India News: Astra Zeneca Vs Ranbaxy!

India News: Astra Zeneca Vs Ranbaxy!!!

AstraZeneca, Ranbaxy settle Nexium fight
AstraZeneca investors were jumping for joy this morning when the drugmaker announced it had played Let's Make a Deal with Indian generics maker Ranbaxy. The copycat company agreed to wait till 2014 to sell its version of the heartburn med Nexium, AstraZeneca's top selling drug with $5.22 billion in revenues.

That's a huge coup for AstraZeneca, which has been fighting off the generic challenge since 2005. But it's also a good deal for Ranbaxy: the Indian drugmaker gets U.S. distribution rights to two off-patent AstraZeneca meds, Prilosec and Plendil, and will start supplying the active ingredient in Nexium to AstraZeneca beginning in 2009.

AstraZeneca still faces patent challenges on Nexium from Teva Pharmaceutical Industries and India's Dr Reddy's, but analysts said that Ranbaxy's willingness to settle may signal the strength of AstraZeneca's case. Market watchers also upped AstraZeneca's target share price.

Dr.Vikram.K
Source: Fierce Bioresearcher

FDA probes Roche, Novartis Medicines:

The transplant drug probe is widening. FDA says it's identified 16 cases of an often-fatal neurological disease among patients taking Roche's CellCept drug, used to prevent organ rejection. The agency will review the reports and work on new labeling for the med over the next couple of months; in the meantime, FDA is warning doctors and patients to look out for neurological symptoms. The agency also is looking at similar risks with Myfortic, a drug made by Novartis that has the same active ingredient, though it hasn't received any reports of the disease in those patients.

You'll recall that Roche alerted FDA to the issue in November after receiving reports of progressive multifocal leukoencephalopathy, which attacks the brain and central nervous system; the disease is usually fatal, and survivors are often permanently disabled. Roche independently confirmed 10 cases of the disease in CellCept patients. Some 500,000 patients worldwide have used the drug, however. European regulators have already added cautionary language to the drug's label; Roche has submitted new labeling to the FDA, but the agency is still reviewing it.

Dr.Vikram.K
Source: Fierce Bioresearcher

FDA:More offices overseas??

More offices overseas??
The FDA has weathered no small amount of criticism over its lax regulation of food and drug safety overseas. In recent months, it seems that hardly a week passes without reports of the FDA's inability to effectively monitor drugmaking in other countries. As the biotech and pharmaceutical industries extend their global reach, ensuring the quality and safety of imported products is an increasingly important issue.
Now the FDA is doing something about it. FDA Commissioner Andrew von Eschenback is hoping to establish five satellite offices in India, China, Central and South America and the Middle East. Currently, FDA workers periodically inspect foreign pharmaceutical plants and clinical trial sites, but visits are only conducted yearly. The new offices would help provide much-needed extra capacity as well as train additional inspectors.
There are details yet to be ironed out. For one thing, the FDA must decide how its inspectors will work with other countries' own drug approval agencies. There's also the issue of how to finance the whole endeavor--a real issue, considering that the FDA is already operating on a less-than-ideal budget.


Dr.Vikram.K
Source: Fierce Bio

DIA conference MUMBAI April28-29,08

DIA 1st Indian Annual Regulatory Conference Building Bridges Between the Regulators and the Pharmaceutical Industry: Indian Regulatory Landscape in the Next Decade

Date(s) And Time(s):
Apr 27 2008 9:00AM - Apr 29 2008 6:15PM

Location:
InterContinental The Grand Mumbai
-
Sahar Airport Road
Mumbai 400059
MH
India

Interest Area(s):
Academic Health Centers, Biotechnology, Clinical Data Management, Clinical Safety/Pharmacovigilance, Clinical Research and Development, Project Management, RA/Policy/Drug or Device Approval/GRP, R&D/Strategic Issues, Outsourcing/Virtual Development, Marketing/Advertising

Overview:

DIA 1st Indian Annual Regulatory Conference continues the DIA tradition of premier multidisciplinary, neutral, and international events.

This conference launches the establishment of a DIA office in Mumbai, and of the DIA provisional Advisory Council of India.

India has a strong need for an international forum that brings together industry, academia, and regulators to educate its drug development professionals on regulations, clinical practices, and safety standards that will impact the approval of drugs developed in India for a global market. Join regulators, industry epresentatives, and academia to share experiences and key objectives that will help to bridge the gap between regulators and industry over the next decade.

TRACK TOPICS

· Challenges and Opportunities in Quality

· Clinical Trials, Safety, and Postmarketing

TWO TUTORIALS – SUNDAY, APRIL 27, 2008

• Quality Overall Summary and Quality Modules • Good Clinical Practices

CONFERENCE OBJECTIVES

· Discuss the Evolving Indian and Global Regulatory Environment

· Recognize the Requirements of Indian Regulations

· Discuss Future Drug Development Science

· Identify Current Challenges around Quality, Safety and Efficacy

· Evaluate International Trends and Global Harmonization Opportunities

Registrations will be accepted by fax only.

Target Audience:

WHO SHOULD ATTEND

This program will benefit individuals involved in:

· Academia

· Clinical research and development

· Clinical safety and pharmacovigilance

· Clinical supply operations

· Clinical trial and project management

· Chemical Manufacturing Control (CMC)

· Compliance

· Data management

· Good clinical practices (GCP)

· Government and public policy

· Medical affairs

· Outsourcing management/contract research organizations (CRO)

· Quality assurance/Quality control

· Regulatory affairs and public policy

· Research and development

· Risk management

· Strategic planning and alliance