Asia Regulatory Roundup: Indian Watchdog Probes Allegations Roche Tried to Influence Regulators (2 May 2017)

Posted 02 May 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.

Indian Antitrust Watchdog Probes Allegations Roche Tried to Influence Regulators

The Indian antitrust watchdog has begun an investigation into allegations Roche tried to influence regulatory agencies and otherwise stop biosimilar copies of Herceptin from gaining market share. Roche is accused of seeking to influence the office of the Drug Controller General of India (DCGI) and other agencies by writing letters raising concerns with biosimilar competitors.

Officials at the Competition Commission of India (CCI) are taking the accusations seriously enough to order their director general to undertake a detailed investigation. CCI adopted the position that further investigation is needed after assessing Roche’s response to allegations made by Biocon and Mylan, drugmakers from India and the US with biosimilar copies of cancer blockbuster Herceptin.

CCI summarized Biocon and Mylan’s complaints and its assessment of their merits as follows: “They have argued that Roche Group has not left any stone unturned to evade their entry and/or penetration in the relevant market. They have highlighted various strategies adopted by Roche Group to influence regulatory and other authorities in its favor.

“When they were not successful in evading entry, Roche Group has approached doctors, hospitals, tender authorities, etc., to influence their perception about the efficacy and safety of the Informants’ products. It, thus, prima facie appears to the Commission that Roche Group has tried to influence regulatory authorities,” CCI wrote in its interim order.

The allegations Roche tried to influence regulators center on a series of letters the company wrote between 2013 and 2016. The first of the letters was sent to DCGI at the time Biocon and Mylan were seeking approvals for their Herceptin copycats. In the letter, Roche is said to have disparaged the development of the biosimilars, claiming Biocon and Mylan had failed to perform the clinical trials recommended in Indian guidance. DCGI approved the biosimilars within two weeks of Roche sending the letter.

As Biocon and Mylan present it, the DCGI approval prompted Roche to switch its attention to other possible barriers to the adoption of their biosimilars. Of the letters Roche wrote after the DCGI decision, CCI picked out missives the company sent out after a Delhi High Court order in April 2016 as suggesting Biocon and Mylan’s complaints have merits.

Roche wrote to the All India Institute of Medical Science on June 3. The letter reportedly referred to a 25 April court ruling that placed restrictions on the labeling and promotion of the biosimilars. Biocon and Mylan’s complaint centers on the fact the letter failed to mention a decision made a few days later upon appeal that they say changed the complexion of the 25 April order.

“This would typically give a public or medical authority the impression that the use of biosimilars are prohibited ... which evidently is not the case,” CCI wrote.

CCI’s willingness to look into the matter opens another front in the long-running fight between Roche and its biosimilar competitors. The matter is also the subject of an ongoing civil suit. 

The publication of the director general’s report in 60 days will give a clearer picture of where Roche and its accusers stand and whether the Swiss pharma will face punishment for its actions.  Reuters quotes an anonymous lawyer at the Delhi High Court as saying the investigation could result in penalties.

CCI Case, Reuters

India Rejects Abbott, Medtronic Requests to Withdraw Stents from Market

The National Pharmaceutical Pricing Authority (NPPA) of India has rejected Abbott Healthcare and Medtronic’s requests to withdraw stents from the market. Abbott and Medtronic wanted to pull their devices from the market on the grounds their sale was rendered commercially unviable by the price ceiling NPPA introduced earlier this year.

NPPA dismissed the device manufacturers’ requests for multiple reasons. Most fundamentally, NPPA said neither company signed its request. This rendered the requests null and void in the eyes of NPPA. The cost watchdog also noted there is no regulatory mechanism for the “immediate withdrawal” requested by the companies.

Abbott and Medtronic could fix the signing failing and refile quickly, but they would still fall afoul of another of the issues raised by NPPA in its responses to the requests. In February, NPPA wrote to Abbott and Medtronic to invoke its power to force them to continue to supply their devices. After assessing the legal situation, NPPA has concluded product withdrawals cannot be considered while the special measures it invoked in February are in force.

In light of this conclusion, NPPA has asked Abbott and Medtronic to wait until two weeks before the six-month duration of the forced supply powers is due to expire before refiling.

The terms of the regulatory powers invoked by NPPA allow it to recommend they stay in force after the initial six-month term is up. NPPA will decide on whether it wants the powers to stay in force two weeks before their scheduled expiry.

The cost watchdog used its rejection of the requests as an opportunity to advise and chastise the companies. NPPA mentioned the legislative provisions for price revision as options Abbott and Medtronic should consider before seeking to withdraw their devices. More critically, NPPA also said the companies should be “more cautious and responsible in taking such business decisions” and noted they have failed to meet the reporting requirements imposed on them through the invocation of its powers in February. 

Abbott wanted to withdraw its Xience Alpine Everolimus Eluting Coronary Stent System and Absorb GT1 Bioresorbable Vascular Scaffold. Medtronic’s request covered its Resolute Onyx Zotarolimus-Eluting Coronary Stent System. The devices are the sort of premium products with claimed innovative features that some observers fear would no longer be economically viable to develop under a price-capped system.  

Abbott Rejection, Medtronic Rejection, Abbott Letter, Medtronic Letter, More

TGA Proposes 12-Month Lifespan for Existing Orphan Drug Designations

The Therapeutic Goods Administration (TGA) of Australia has proposed a transitional arrangement covering its reform of the orphan drug process. TGA plans to have all existing orphan drug designations lapse 12 months after the new program comes into force.

The proposal reflects TGA’s current position on the lifespan of orphan drug designations. Under the new model TGA plans to bring in, the orphan drug designations it awards will last six months. Companies will have an option to request a six-month extension. This approach differs from the current open-ended approach to orphan drug designations, and as such TGA is seeking a way to move smoothly from one regime to the other.

TGA sees the 12-month lifespan for existing orphan drug designations as giving companies time to adjust to the new regulatory program. For companies that applied for orphan drug status early in development, the new, finite durations of their designations may mean they have to let them lapse and refile when they are closer to market.

The regulator has given the industry until May 19 to comment on its plans for the transition. The next date of note after that is 1 July, when the new orphan drug regulations will come into effect.

TGA Letter

Other News:

The China Food and Drug Administration (CFDA) has continued its hiring push by unveiling plans to recruit 100 people. CFDA is seeking people with medical and statistical backgrounds to work at its drug review center, one of the units that has struggled to keep up with growing workloads in recent years. CFDA put out an advert for 89 jobs last month. CFDA Notice (Chinese)

 

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Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Regulatory strategy, Regulatory intelligence, News, Asia, CFDA, CDSCO, TGA

Tags: Medtronic, Abbott, Roche, Herceptin, biosimilars

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