Generics/General
Also noted on generics: 16 March 2012
Prescription drugs to be directly dispensed by pharmacists
FDA has announced a meeting to be held on 22 and 23 March 2012 to discuss the possibility of allowing some prescription drugs to be dispensed by pharmacists without the need for a physician’s prescription.
Source: Federal Register
FDA approves new suppliers to alleviate cancer drug shortages
Two new suppliers of cancer treatments have been approved by FDA to try to alleviate ongoing US drug shortages.
WHO definitions of generics
Confusion often surrounds terms used in the global field of generics and biosimilars.
Commission urges Greece to make parallel trade fair
The European Commission announced on 26 January 2012 that it wanted Greece ‘to establish fair play on parallel importation of medicinal products’.
Italian physicians’ negative attitude to generics
A row over generics prescribing has erupted in Italy, with the government and physicians at odds over changes to prescribing rules.
The pharmaceutical market in Brazil
The Brazilian pharmaceutical market is the third largest in the Americas region, after Canada and USA, it ranks first in the Latin American region. Pharmaceutical demand will continue to rise, fuelled by increasing disposable income, therefore, the market outlook is positive for the 2011–2016 period.
European Commission investigates Johnson & Johnson and Novartis over delaying generics
As part of its ongoing antitrust investigations, the European Commission (EC) announced on 21 October 2011 that it is looking into agreements between Johnson & Johnson (J&J) and Novartis to determine whether they delayed the entry of a generic version of the fentanyl painkiller in The Netherlands. If the drugmakers had ‘contractual arrangements’ that hindered a generic drug, this would ‘potentially’ breach EU antitrust rules.
Quality by design for generics by 2013
Quality by design (QbD) is already being implemented by FDA for new drug applications, but now, in an attempt to prepare generics manufacturers for QbD in 2013, FDA is preparing to publish immediate and modified release QbD examples.
European Commission to investigate patent settlements again
The European Commission (EC) has once again requested information from pharmaceutical companies regarding patent settlement agreements concluded in the European Economic Area (EEA) in 2010 between originator and generic companies.
Row continues over drug shortages
Unhappiness about persistent drug shortages is becoming more acute, both in Europe and the US. Hospitals in The Netherlands are routinely short of around 40 products, whereas in the US 180 medications have now made it onto FDA’s list of scarce products. Hospital pharmacists spend an increasingly large amount of time trying to source scarce items and, despite their best efforts, doctors and patients are increasingly noticing the scarcities.
