Policies & Legislation

Application fees increase for prescription drugs

Home/Policies & Legislation | Posted 06/10/2017

US Food and Drug Administration (FDA) application fees for prescription drug approvals are to increase by almost 20% for FY2018, beginning from October 2017. Biosimilar user fees however will decrease.

Ireland consults on National Biosimilar Medicines Policy

Home/Policies & Legislation | Posted 08/09/2017

Ireland’s Department of Health (DoH) has begun a consultation on its biosimilars policy amid criticism from the country’s pharma industry.

FDA user fee reauthorization bill passes US House of Representatives

Home/Policies & Legislation | Posted 11/08/2017

The US House of Representatives passed a bill on 12 July 2017 reauthorizing the US Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar and medical device user fee programmes.

US states progress drug-pricing legislation

Home/Policies & Legislation | Posted 14/07/2017

With attention being increasingly focussed on the price of drugs in the US, and with federal action on drug prices and cost transparency having stalled in Congress, several states have moved forward with their own legislation.

Quebec hopes to save millions by tendering for generics

Home/Policies & Legislation | Posted 07/07/2017

The Health Ministry in Quebec, Canada is launching a tender process for generics in an attempt to save millions of dollars. It is hoped that the new system will make medication cheaper for patients and save taxpayers CA$300 million per year.

EMA launches new EudraVigilance system for adverse reactions

Home/Policies & Legislation | Posted 30/06/2017

The European Medicines Agency (EMA) announced that it will launch a ‘new and improved version of EudraVigilance’ in November 2017, which will contain enhancements for reporting and analysing suspected adverse reactions.

US Senate revives the CREATES Act

Home/Policies & Legislation | Posted 23/06/2017

The US Senate and House Judiciary Committees have reintroduced legislation to tackle anticompetitive behaviour that delays the market entry of more affordable generic drugs.

Notice can be given before FDA approves biosimilar

Home/Policies & Legislation | Posted 16/06/2017

In a landmark decision by the US Supreme Court, biosimilars makers will be able to give notice to the originator manufacturer before the US Food and Drug Administration (FDA) has given final approval of the biosimilar.

Generics association recommends FDA regulation changes

Home/Policies & Legislation | Posted 09/06/2017

The Association for Accessible Medicines (AAM) has recommended five changes to US Food and Drug Administration (FDA) regulation, including allowing abbreviated new drug application (ANDA) sponsors the same rights as those for non-generic drugs.

Lawmakers urge CMS to reverse its biosimilars policy

Home/Policies & Legislation | Posted 26/05/2017

Senator Pat Roberts and Representatives Joe Barton and Anna Eshoo, along with a delegation of 52 House Members and nine Senators, have asked the Centers for Medicare & Medicaid Services (CMS) to reverse its biosimilars policy.

US introduces two new bills to promote generics

Home/Policies & Legislation | Posted 12/05/2017

The Fair Access Safety and Timely Generics Act has been reintroduced to congress, promising to save the US billions of dollars each year, while California has introduced a bill that would ban the use of coupons for prescription drugs where a cheaper alternative exists.

How will the timing of BPCI Act 180-day notice affect biosimilars?

Home/Policies & Legislation | Posted 04/05/2017

On 26 April 2017, the US Supreme Court heard oral arguments in Amgen vs Sandoz. The case has come to the Supreme Court after the Court of Appeals for the Federal Circuit made the controversial ruling that the so-called ‘patent dance’ was optional, but also that the 180-day notice could only be given after the 12-year exclusivity period ended.

Maryland has increased power over drug prices

Home/Policies & Legislation | Posted 21/04/2017

The US Food and Drug Administration (FDA) announced on 2 March 2017 that the state of Maryland General Assembly was considering two bills that would require pharmaceutical companies to notify the state ahead of drug price increases. On 20 March 2017, one of these bills that sets out to ban excessive price increases for generics and off-patent drugs, was passed. In the US, legislation related to pharmaceuticals can vary across states [1].

UK authority accuses Actavis UK and Concordia of illegal agreement

Home/Policies & Legislation | Posted 07/04/2017

The UK’s Competition and Markets Authority (CMA) alleged that pharmaceutical companies, Actavis UK and Concordia, entered into illegal agreements that allowed them to increase and maintain high prices of hydrocortisone tablets.

India and Argentina call for hepatitis C generics

Home/Policies & Legislation | Posted 31/03/2017

The high prices of hepatitis C drugs push the need for more generic versions to be approved worldwide. On 13February 2017, Médecins Sans Frontières (MSF, Doctors Without Borders) reported that organizations in India and Argentina filed cases against the patents of certain hepatitis C drugs.