Policies & Legislation
FDA gives details of generic drug user fees
FDA has detailed the amounts that generics and active pharmaceutical ingredient manufacturers will have to pay under the Generic Drug User Fee Amendments of 2012 (GDUFA).
India issues more compulsory licences
The Indian Government is once again planning to issue compulsory licences for three patented cancer drugs, allowing local drugmakers to launch generic versions of the drugs before the patents expire on the originator drugs.
India’s patent office at odds with Big Pharma
India and its patent laws are increasingly being challenged by Big Pharma. In its most recent decision, the Indian Patent Office has rejected AstraZeneca’s patent appeal on Iressa (gefitinib). Somewhat controversially the office has been asked by the Supreme Court, however, to reconsider Pfizer’s patent on Sutent (sunitinib). Meanwhile, it is still to issue a final verdict in Novartis’ legal challenge against India’s patent laws.
Generic pre-emption raises its ugly head again
The US Supreme Court is to review a case, which could determine whether generics companies can be held responsible for design flaws in the drugs they copy.
FDA to tighten control over generics
A single incident of an extended-release formulation that released its drug too quickly has caused FDA to change its policy. An FDA official said in October 2012 that the agency would be looking more closely at the techniques generics drugmakers use to make extended-release drugs.
Major shake-up of API import rules in Europe
EU is seeking to impose good manufacturing practice (GMP) standards throughout the world in an attempt to stop the import of counterfeit or substandard active pharmaceutical ingredients (APIs) for human-use medicines. The new rules will come into force next year.
Pharmaceutical trade barriers are falling
The European Parliament has voted in favour of a trade pact between Israel and the European Union (EU) that will allow easier access to medicines from both markets. The EU is also seeking to reduce barriers to other Mediterranean neighbours and Canada.
India patent laws under close scrutiny
The international pharmaceuticals community is watching closely as Pfizer appeals against a decision to revoke its patent on Sutent (sunitinib).
Generic drug user fees come into effect
Legislation allowing FDA to collect several user fees under the Generic Drug User Fee Amendments of 2012 (GDUFA) was approved by the US Congress’s House Energy and Commerce Committee on 21 September 2012. FDA User Fee Corrections Act of 2012 amends the FDA Act to address certain issues raised by language included in the GDUFA.
MSF launches online ‘Patent Opposition Database’
The international medical humanitarian organisation Doctors Without Borders/Médecins Sans Frontières (MSF) has launched an online resource to help civil society and patient groups in developing countries challenge unwarranted drug patents.
