Business-in-Brief

Approvals

• This year marks another record for the number of US generic drugs that have been approved. The FDA has approved 763 generics (927 if tentative approvals are included) during their 2017 fiscal year (ending October 1st) which is 112 more approvals than 2016, continuing the upward trend of generics approvals over the past few years. This correlates with the increased number of Abbreviated New Drug Applications (ANDAs) submitted over last year, which the Regulatory Affairs Professionals Society attributes to the 1000 new employees the FDA were able to hire thanks to the first Generic Drug User Fee Amendment (GDUFA). More Information.
• A study published in the BMJ set out to determine the quality of life benefits that chemotherapeutics in Europe offer (1). The researchers studied drugs approved by the EMA between 2009–2013, and to the surprise of many concluded that most of those drugs showed little to no benefit for quality of life or survival. The study included data from a minimum of 3.3 years after market entry, and found that the chemotherapeutics offered marginal survival gains over existing treatments or placebos. More Information.

Controversy

• Following Allergan’s controversial patent deal with the Saint Regis Mohawk Tribe, four US senators have co-signed a letter to the Senate Judiciary Committee Chairman to combat the action. They describe Allergan’s deal with the Tribe for their eye drug Restasis as a “blatantly anti-competitive attempt to shield its patents from review and keep drug prices high” (1). Their letter calls for an investigation into the unique scenario since the senators think that companies should not be allowed to pay Tribes or States to invoke their sovereign immunity at the expense of patients. More Information.
• A coalition of 41 attorneys general in the US have banded together to investigate opioid marketing practices and have issued subpoenas to several pharma companies including Endo, Janssen, Teva, and Allergan. A supplemental investigative subpoena has also been sent to Purdue Pharma, and some distributors have also been asked to hand over documents. In a letter to America’s Health Insurance Plans, attorneys general also urged insurers to prioritize non-opioid treatments (2). More Information.

Regulation

• The EMA has issued an update about its relocation plans post-Brexit. The agency has received bids from 19 EU countries and has undertaken a thorough assessment of each. At the moment, the preferred options seem to be Amsterdam, Barcelona, Copenhagen, Vienna, or Milan. The assessment considered the proposed buildings, accessibility of location, existence of adequate education facilities, appropriate access to the labor market, social security, medical care, and business continuity. Potential staff retention for each candidate location has also been considered. EU member states will vote on the move in November. More Information.
• Back in July, the Association of the British Pharmaceutical Industry (ABPI) challenged the UK’s cost watchdog – the National Institute for Health and Care Excellence (NICE) – over the introduction of an additional negotiation process for drugs that have already been assessed as cost-effective for the country’s National Health Service, arguing that the decision could cause significant delays to patients waiting for treatment. The UK’s High Court recently denied the judicial review, and the ABPI says it will not seek an appeal against the decision, meaning that the additional review process will stand and, according to NICE, could impact one in five medicines. More Information.
• Emerging manufacturing technologies such as continuous manufacturing and 3D printing have been given finalized guidance by the FDA. The growing advances in these technologies have urged the agency to update their preliminary draft from 2015. The completed guidelines state a partnership between the FDA’s emerging technology team, the Office of Compliance, and Office of Regulatory Affairs to conduct on-site evaluations and assist with final quality recommendations for approval submission. More Information.