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Drug shortages increase again in 2011
Despite efforts by FDA the number of drugs in short supply has increased again in 2011, according to data from the University of Utah, USA. Levels are more than 4.5 times higher than in 2004, when 58 drugs were reported to be in short supply, and have reached a new record high of 267 drugs experiencing shortages.
Related article
Record high drug shortages in the US
Source: The Washington Post
European regulators agree that full clinical trial data should be published
European regulators agree that the results of clinical trials of authorised drugs should be published. In an article called ‘Open clinical trial data for all? A view from regulators’, published on 10 April 2012 in PLoS Medicine, a group of regulators examine the reasons for and against open access of these data, and come to the conclusion that open access could lead to public health benefits through independent analysis and the development of predictive models.
The article is freely available at:
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001202
Source: EMA
Senator backs bill requiring companies to notify FDA of drug shortages
A bill pending in congress would give federal health officials more options for preventing prescription drug shortages affecting patients in the US, according to US Senator Dick Durbin.
Senator Durbin said he is co-sponsoring a bill called the Preserving Access to Life-Saving Medications Act, which would require drug manufacturers to notify federal officials of a disruption to a drug supply six months in advance. ‘That would give FDA an opportunity to prevent the shortage, notify healthcare providers and develop a contingency plan’ he added.
Source: State Journal Register
India track and trace system to fight counterfeit drugs
In an attempt to stop counterfeit drugs entering the market sold under the Indian brand a task force was set up by the Indian Health Ministry in 2011. The task force has recommended the adoption of SMS texting and unique identification codes as the most ‘viable and affordable’ methods for the Indian pharma industry to implement the track and trace system.
Source: Pharmabiz
FDA Internet pharmacy warnings may go too far
FDA has warned people about the dangers of buying prescription drugs from foreign pharmacies via the Internet. However, a recent economic analysis by the National Bureau of Economic Research suggests that FDA’s stance on the matter might go too far, especially in light of the fact that many Americans do not fill their prescriptions because they cannot afford to.
The study acquired 370 drug samples from 41 online pharmacies and tested their authenticity. While the findings of the report confirmed FDA warnings against rogue websites, it also found that ‘a blanket warning against any foreign website may deny consumers substantial price savings.’
Source: National Bureau of Economic Research
No worries for Serbian Actavis unit
Generics manufacturer Actavis Group told Bloomberg its production unit in Serbia is ‘doing well and won’t be affected by a possible acquisition’.
Rumours are that Actavis may be ripe for a takeover by Watson Pharmaceuticals. However, Actavis spokesman Mr Frank Staud denied job cuts may ensue after a takeover, saying ‘I would not be worried at all about Serbia’, adding that ‘we are doing very well in Serbia. It’s one of our most important plants.’
The Serbian unit was acquired by Actavis in 2002 for Euros 3.5 million and is the third-biggest manufacturer in Serbia.
Source: Bloomberg
Fake drugs in India fall by 40% in 2010 despite increased testing
The number of ‘spurious or adulterated’ drugs found in India in 2010 was 95, compared to 157 in 2008, despite increased testing by authorities. The trend looks set to continue with the number of fake drugs reported for the first six months of 2011 being 41.
Source: Indian Ministry of Health & Family Welfare, InPharma Technologist
Teva sells Quebec plant
Teva Canada announced on 28 March 2012 that it had sold its Quebec manufacturing facility to US contract manufacturing organisation (CMO), Halo Pharmaceutical. Teva said that 150 of the 340 employees at the plant would also transfer to Halo. The deal is expected to be finalised on 30 June 2012.
Source: Halo, Teva
New counterfeit bill introduced
On 27 March 2012 Congressman Ted Poe and Congressman Steve Chabot introduced bill HR4216, the Foreign Counterfeit Prevention Act. The legislation aims to allow US Customs and Border Protection to exchange information with businesses in order to protect intellectual property rights and to find counterfeit products.
However, this bill covering all foreign counterfeit products, not just pharmaceuticals, caused disagreement amongst the US Crime, Terrorism and Homeland Security Subcommittee when they met to discuss counterfeit prescription drugs.
Source: Ted Poe
New decree for the prescription and commercialization of medicines in Argentina
FDA issues draft guidance on biosimilars and interchangeable biosimilars labelling
Strategic plans of ANVISA and COFEPRIS to advance health regulation
Panama enacts new bill to guarantees the supply of medicines
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