Here are 3 brief news for your quick update:

• US FDA Approves 4 Vaccines for H1N1 Influenza
• Pfizer fined US$2.3bn for illegal drug promotion
• India’s Generic Dispute with EU Near Settlement

The US FDA has approved four vaccines for use against the 2009 H1N1 influenza virus. Made by— a) CSL Limited, b)MedImmune LLC, c) Novartis Vaccines and Diagnostics Limited, and d)Sanofi Pasteur Inc.—will be distributed throughout the US after the initial lots become available. This is expected to occur within the next few weeks.

Commissioner of Food and Drugs Margaret A. Hamburg, M.D., says the approval is good news for the nation's response to the 2009 H1N1 influenza virus. "The vaccine will help protect individuals from serious illness and death from influenza," she says.

Vaccines against three seasonal virus strains are already available and should be used. However, they do not protect against the 2009 H1N1 virus.

What have studies of the H1N1 vaccines shown?
Based on preliminary data, the approved vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine.

Clinical studies under way will provide more information about the optimal dose in children. Recommendations for dosing will be updated if indicated by findings from those studies. The findings are expected in the near future.

What are the warnings and potential side effects?
In the ongoing clinical studies, the 2009 H1N1 vaccines have been well tolerated. However, consumers need to be aware of the following:

• People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

• Potential side effects of the H1N1 vaccines are expected to be similar to those of seasonal flu vaccines. For the injected vaccine, the most common side effect is soreness at the injection site. Other side effects may include mild fever, body aches, and fatigue for a few days after the inoculation. For the nasal spray vaccine, the most common side effects include runny nose or nasal congestion for all ages, sore throats in adults, and—in children 2 to 6 years old—fever. (Also see seasonal flu information in the "For More Information" section below.)

• As with any medical product, unexpected or rare serious adverse events may occur.

FDA is working closely with other agencies to enhance adverse-event monitoring, information sharing, and analysis during and after the 2009 H1N1 vaccination program. In the U.S. Department of Health and Human Services, these agencies include the Centers for Disease Control and Prevention (CDC).

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Pfizer was fined US$2.3 billion for illegally promoting drugs for indications not approved by drug regulator.The civil settlement also implicated Pfizer’s alleged bribes and offers of lavish hospitality to healthcare providers to encourage them them to prescribe four of the company's drugs. These were BextraTM (an anti-inflammatory), GeodonTM (an anti-psychotic), ZyvoxTM (an antibiotic) and LyricaTM (an anti-epileptic).

In entering the guilty plead, Pfizer would have to enter a corporate integrity agreement  apart from the criminal fine of US$1.195bn and a subsidiary company of Pfizer - Pharmacia & Upjohn - will forfeit US$105m. The remaining $1bn fine was levied to resolve the allegations under the civil False Claims Act.
This investigation was triggered by the action of six whistleblowers who alerted the authority, and this ultimately resulted such a monumental fine with a windfall for each of the whistleblower who will receive US$102m each from the civil fines paid by Pfizer.

Pfizer reported a 90% drop in profit to $268m in the fourth quarter of 2008, because of the $2.3bn legal settlement, indicating that the company was aware they would be paying this sum before the terms of the deal with the Department of Justice were announced.

India seems ready to bring a case before the WTO Dispute Settlement Body (DSB), which handles complaints of possible WTO rules violations against the European Union, then there are procedures that it must follow. The first stage of a dispute is consultations between the parties, which, if they do not lead to resolution, could lead to the formation of a dispute panel, and ultimately sanctions.
Concerns over the confusion between counterfeit, a term of art at the WTO covering trademark violations, and generic medication have been ongoing in several international agencies, particularly at WHO. The trigger that set off the disputes was due to the fateful shipment of 500kg of Dr. Reddy’s anti-hypertensive drug destined for Brazil being impounded by Dutch authority  in December 2008. The drug was patented in neither India nor Brazil and was held for 36 days in a Dutch port before being released and taken back to India. This prompted outcry from Brazil and India as well as a collection of public health civil society groups seeking to stop those “acting with impunity to thwart lawful generic competition”.
Alarm escalated with a second delay of generics, this time antiretrovirals in transit from India to Nigeria was  detained.Then a freedom of information act request submitted to Dutch authorities revealed that there had in fact been 17 shipments detained in 2008 (vide eBulletin No. 43). The Dutch response said that 16 of the delayed shipments had come from India (and one from China). The information from the Netherlands and one more case of delay in 2009 in Frankfurt – a shipment of generic antibiotic Amoxicillin, also from India – prompted an intervention from the
Particular concerns expressed by India were that the delay violated “principles set out” in Articles 7 and 8 of the TRIPS agreement. Brazil added that a “decision to impede the transit of cargos of generic medicines violates the freedom of transit” in a statement issued at the same meeting. The EU argued that  the seizures were only “temporary detention for customs inspections” as they were not permanently prevented from getting to their destination. With no resolution in sight, it appears that a settlement through DSB will be inevitable for the quarrels of the generics.