Asia Regulatory Roundup: Pfizer Asks TGA to Rethink Timeline for Biologics AE Reporting (14 March 2017)

Posted 14 March 2017 By Nick Paul Taylor

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Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Pfizer Asks TGA to Rethink Proposed Timeline for Biological Adverse Event Reporting

Pfizer has asked the Therapeutic Goods Administration (TGA) of Australia to reconsider proposed timelines for reporting adverse events related to biologicals. The drugmaker wants TGA to mirror the reporting requirements for other medicines, rather than introduce the tighter timelines it put forward in draft biovigilance guidance last year.

TGA has proposed that sponsors of human tissue and cell-derived products classed as biologicals must report serious threats to public health in writing within 48 hours of becoming aware of theadverse event. The agency plans to give sponsors of biologicals 10 calendar days to report serious adverse events that led to the death or serious deterioration in the health of a patient. For events that could lead to death or deterioration if they happened again, TGA plans to give sponsors 30 days to file a report. Electronic forms are available for the 10- and 30-day reports.

Those proposed timelines have attracted the notice of Pfizer, which wrote to TGA to question the divergence from the pharmacovigilance requirements for other, non-biological medicines. TGA gives sponsors of medicines 72 hours to report significant safety issues and 15 days to file reports about serious adverse events. 

“My understanding is that in the [European Union] that there are no plans to make the reporting timeframes for biologicals different to those for medicines as in the recent update there was no change to reporting timelines,” the Pfizer representative wrote.

Pfizer’s comment about the EU refers to the guideline on good pharmacovigilance practices (GVP) for biological medicines the European Medicines Agency (EMA) brought into force in August. That document takes its reporting timelines from module VI of EMA’s GVPs, in which sponsors are given 15 days to report serious adverse events.

With EMA, which TGA frequently looks to for regulatory guidance, seemingly content to apply general pharmacovigilance rules on reporting timelines to biologicals, Pfizer wants Australia to follow suit. TGA has not adopted module VI of the EU GVPs.

TGA published Pfizer’s feedback alongside comments from Novartis, the Eye Bank Association of Australia and New Zealand and the Biotherapeutics Association of Australasia, the only organizations to submit responses and consent to their publication. None of the other respondents raised concerns with the reporting timelines proposed by TGA.

Pfizer Response, More

TGA Discovers Counterfeit ‘Placebo’ Tablets Containing Clenbuterol

TGA has posted a warning about a product branded “placebo” that contains clenbuterol, an asthma drug with a history of off-label use by bodybuilders, dieters and athletes. The warning follows a TGA investigation that found people in Australia have bought the product online.

A photograph of the product packaging shows a mix of Chinese and English language text. The English sections of the packaging feature the phrases “sample not for sale,” “made in China” and “placebo.” TGA’s testing of the product found it contains undeclared beta2-adrenergic agonist clenbuterol, a drug approved for use in Australia on a prescription basis. Neither the “placebo” product nor its place of manufacture have been assessed and approved by TGA.

In response to the findings of the investigation and product testing, TGA has told consumers to stop taking the tablets and begun working with the Australian Border Force (ABF) to intercept shipments as they enter the country. Tablets found at the border will be seized and destroyed.

TGA issued the warning about the clenbuterol placebo tablets alongside a report of a more typical case of counterfeiting. The second report covered the testing of tablets purporting to contain 100 mg of tadalafil, the active ingredient in Eli Lilly’s erectile dysfunction drug Cialis. TGA found the tablets contained trace amounts of sildenafil — the active ingredient in Pfizer’s Viagra — and the banned analgesic dipyrone. Neither ingredient was declared on the label.  

The agency is also working with ABF to stop the tadalafil product coming into the country and is advising consumers to stop taking the tablets.

TGA Warning, More

India Orders Makers of 22 Types of Medical Devices to List Maximum Price on Packaging

The National Pharmaceutical Pricing Authority (NPPA) of India has ordered producers of 22 types of medical devices to list the maximum retail price (MRP) on their product packaging. The demand follows shortly after NPPA signaled its intent to pay greater attention to the medical devices sector by capping the price of cardiac stents.

NPPA’s latest action covers the 22 types of medical devices classed as drugs by Indian regulations. The list of devices includes disposable syringes, heart valves and orthopedic implants. As products classed as drugs under the Indian regulatory framework, these devices are covered by the Drug Price Control Order (DPCO), 2013. Most of the devices are classes as non-scheduled formulations. This status places certain obligations on manufacturers of the devices.

The status of these products has not changed, but with NPPA paying more attention to medical devices following the stent price cap, the cost watchdog has informed manufacturers of their obligations under DPCO.  

Notably, the device makers must display the MRP and phrase “inclusive for all taxes” in indelible ink on the packaging of their products. Manufacturers must also send a price list for their products to “dealers,” state drug controllers and the government. Retailers are prohibited from selling the products for more than their MRPs, and manufacturers are banned from increasing their prices by more than 10% a year.

NPPA is working to make device makers comply with DPCO in parallel to its attempts to enforce the recently introduced cap on the price of drug eluting and bare metal stents. Over the past week, NPPA has expanded its investigation into reports of overcharging to cover 32 hospitals. NPPA has received responses from eight hospitals. An audit of 78 angioplasty cases at Metro Hospital, Faridabad, discovered two cases of overcharging. 

NPPA Letter,Stent Complaints, More

Pakistan Expands List of Registered Cardiac Stents as Price Control Plans Advance

The Drug Regulatory Authority of Pakistan (DRAP) has extended its list of registered cardiac stents. DRAP’s revision of the document, which was originally released during the stent scandal in January, coincided with a meeting convened by the government to discuss the pricing of such devices. 

Pakistan turned its attention to the cardiac stent market after the Federal Investigation Agency (FIA) alleged hospitals were profiteering from the products, either by overcharging or implanting them in patients who did not need treatment. That led to DRAP raiding and sealing the office of a multinational company and publishing a list of stents registered for sale in Pakistan. That list was updated late last week.

The News reports the update follows a meeting in February to consider applications for cardiology medical devices. In the weeks after that meeting, DRAP reportedly met to draft a pricing plan for medical devices. The proposal would cap stent prices at 50% above the import price. That ceiling is intended to prevent hospitals from overcharging, much like the cap introduced by NPPA in India.

DRAP had a chance to discuss its proposal at a meeting held by the government late last week to go over the issue of stent pricing. As The Times of India reported, Pakistan’s interest in controlling the prices of stents is part of a broader trend in South Asia. Bangladesh, Pakistan and Sri Lanka are among the countries considering following India and capping stent prices. 

DRAP List, The News, The Times of India

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Categories: Biologics and biotechnology, Drugs, Medical Devices, News, Asia, CDSCO, TGA

Tags: Asia Regulatory Roundup, Pfizer, NPPA, stents

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