July roundup: Regulators experience a busy month

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Martin Barraud)
(Image: Getty/Martin Barraud)

Related tags: Fda, Ema, Cannabidiol, Apotex, Biohaven, Strides, Opioid epidemic, Emerade

July has seen a number of actions taken by regulators to manage the supply of medicine, including a crackdown on CBD manufacturers and repackers of opioid medication.

1.Taking a stance on CBD claims

The US Food and Drug Administration (FDA) has tackled one of the fastest-growing industries by sending a warning letter​ to the ‘world’s largest’ cannabis company regarding claims it made for its cannabidiol (CBD) products.

The CBD area has grown rapidly in recent years, with the pharma industry keeping an eye on the development​, but as yet there is only one FDA approved product​ for a medical use. As a result, the FDA took direct action when Curaleaf made therapeutic claims regarding cancer, Parkinson’s disease and opioid withdrawal for its CBD products.

2. ALS product rejected based on manufacturing partner

Biohaven had taken its product in front of the FDA for potential approval for the treatment of amyotrophic lateral sclerosis, only for the agency to issue a complete response letter​ (CRL) based on the company’s use of active pharmaceutical ingredient (API) produced by Apotex.

The API was used in a bioequivalence study in 2017 and had been produced by Apotex between 2014 to 2016. Apotex subsequently experienced manufacturing issue, leading to the withdrawal of 31 of its drug products​.

Biohaven’s application was rejected despite the company working with a different supplier of the API for the commercial production of the product.

3. Scrap yard not the suitable location for GMP documents

During an FDA inspection of Strides’ facility in Puducherry, India, the regulator came across a number of issues that resulted in a warning letter being delivered​ to the company. Most notable of the issues was the discovery of a binder of current good manufacturing practice (cGMP) documents in a drum in the company’s scrap yard.

In further causes for concern noted by the FDA, the agency questioned the effectiveness of the company’s quality unit and the accuracy of the cGMP documents that were examined.

4. Opioid repackers in the headlights

The issue that North America is facing with opioid-based painkillers is well-documented​ but the investigation into this side of the industry has revealed further issues, leading to the FDA warning repackers about quality issues of APIs. In particular, the agency found that there were problems regarding sub-potent APIs​, as well as a risk of cross-contamination between APIs due to inadequate cleaning.

The findings led the FDA to issue warning letter to three companies, B&B pharmaceuticals, Asclemed and Spectrum. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, suggested that the findings posed “a real threat to the public health”​ and called on those involved to address the issues within the supply chain.

5. Failure of allergy pens

The shortage of EpiPens globally​ has caused uptake of alternative adrenaline delivery devices to increase; however, one such alternative experienced difficulty in the UK, after the Medicines and Healthcare products Regulatory Agency (MHRA) discovered that Emerade syringes had a low chance of failure​.

In the end, no recall was instigated due to the difficulty in sourcing alternative products and the limited risk of failure when patients carried two such products, as is the recommended guidance.

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