A European Court has issued a ruling in an unlikely scenario dealing with overlapping periods of orphan product market exclusivity. In its ruling, which has the potential to influence how companies develop orphan products, the court found that authorized orphan products are entitled to market exclusivity, even when they are similar to an already approved product. Background Orphan product designation was first introduced in the EU in 2000 under Regulation (EC) No 141...

Regulatory Authorities are challenged to keep their markets open and to ensure that patients have proper access to devices while at the same time keeping non-compliant, possibly dangerous devices away from their populations. To achieve this they need to use risk control strategies. Authorities that are rethinking their approaches to risk management could consider a three-tier system: A 100% check on all devices for a limited number of items per device; A more extensive...

The generic pharmaceutical sector is calling on the US Food and Drug Administration (FDA) to make changes to a proposed policy that would make it easier for regulators to prioritize the review of some new generic drug products for which there is no previously approved generic. Background In August 2014, FDA released a new policy that proposed a major change to the agency's generic drug review policies. Traditionally, FDA has mostly operated on a first-to-file system in ...

Two US senators have proposed new legislation that would grant an unprecedented 15 years of marketing exclusivity to certain types of pharmaceutical and biopharmaceutical products. Background The bill, known as the Dormant Therapies Act of 2014, is the second piece of legislation introduced in as many days by Sens. Orrin Hatch and Michael Bennet (D-CO). The duo introduced the Promise for Antibiotics and Therapeutics for Health (PATH) Act on 10 December 2014. R...

A recent US district court decision could affect US Food and Drug Administration (FDA) interpretation and determinations in the orphan drug exclusivity area. Specifically, on 5 September 2014, the United States District Court for the District of Columbia issued its memorandum opinion in the case of Depomed Inc. v. United States HHS . 1 The case centers on the Orphan Drug Act , which provides incentives to pharmaceutical companies to research and develop drugs for rare ...

A new bill introduced in the US House of Representatives would grant existing pharmaceutical products an additional six months of marketing exclusivity if a company is able to demonstrate the product is able to treat or prevent a rare disease or condition. Background The bill, the Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014 (OPEN ACT), appears to be loosely modeled off a similar plan in place for pediatric products. Under the US Food a...

How should the US Food and Drug Administration (FDA) define the term "first-to-file" when it comes to approving new generic drug products? While the question seems small, at stake is nothing less than potentially billions in savings for consumers and the US government. Background In 2012, Congress pushed through a major piece of legislation to overhaul various aspects of how FDA regulates products. The law, the Food and Drug Administration Safety and Innovation Act (FD...

On Friday, two companies were the lucky recipients of gifts never before given by the US Food and Drug Administration (FDA)—gifts potentially worth millions, if not billions of dollars in value. Background In the US, pharmaceutical manufacturers who obtain approval to market a "new" drug from FDA are eligible for varying degrees of market- (rather than patent-) based exclusivity. For New Chemical Entities (NCEs), that means five years of protection during which time FD...

The US Food and Drug Administration (FDA) has finalized a new policy which will for the first time allow new fixed-dose combination  (FDC) drugs consisting of at least one new drug product to be eligible for five years of so-called "New Chemical Entity" (NCE) exclusivity. But in a setback for companies with existing FDCs, the agency will not apply the policy retroactively. Background In the US, pharmaceutical manufacturers who obtain approval to market a "new" drug from...

US drug regulators are getting ready to take a close look at the regulation of generic drugs, including new policies recently proposed by the US Food and Drug Administration (FDA) and areas that could stand to benefit from additional regulation. Background In a new Federal Register notice posted on 18 August 2014, FDA said it will soon hold a meeting to focus on the implementation of the Generic Drug User Fee Act (GDUFA), a program passed as part of the 2012 Food and...

The US Food and Drug Administration (FDA) today released a new draft guidance document intended to explain how biological products approved under Section 351(a) of the Public Health Service Act (PHS Act) are given periods of market exclusivity. Background Under the Patient Protection and Affordable Care Act's (PPACA) Biologics Price Competition and Innovation Act (BPCI), new biological products are eligible for 12 years of market exclusivity during which time the US...

Generic pharmaceutical manufacturer Mylan says it plans to sue the US Food and Drug Administration (FDA) after regulators declined to grant 180 days of market exclusivity for its generic version of Pfizer's Celebrex (celecoxib). Background Under the 1984 Hatch-Waxman Act , companies are allowed to file for approval for a generic version of a drug once the original product's patent and market-based exclusivity provisions end. To incentivize companies to challenge the va...