Indian Express: New Delhi: Monday, July 24, 2017.
Abbott has
submitted a plan to conduct phase-4 trials of its two next-generation stents Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS to the
Central Drugs Standard Control Organisation (CDSCO), on June 22. The Absorb BVS
has been partially withdrawn from Australia and Europe after latest studies
showed that there is an increased risk of “major adverse cardiac events” in
patients receiving the BVS, when compared with the ones who received the
company’s older drug-eluting stent named Xience. Meanwhile, till July 7, the
CDSCO did not receive “any adverse event report” against the aforementioned two
next-generation stents.
On April 7,
India’s central drug regulator issued a medical device alert asking the doctors
and patients to report any adverse events related to the use of these two stents.
“As per records available, this office has not received any adverse event
report,” the CDSCO stated in response dated July 7, 2017, to an application
filed under RTI Act, 2005 by The Indian Express.
The CDSCO
added in its RTI reply: “The Subject Expert Committee (SEC) recommendations
have been communicated to the firm and the firm has submitted future plan to
this office on June 22, 2017, and same will be deliberated in the forthcoming
SEC meeting.” Phase-4 trial is the final stage in clinical trails. The next SEC
(Cardiovascular and Renal) meeting, where the company’s plan would be examined
and subsequently approved, is likely to happen after two-three weeks, according
to a senior CDSCO official.
The matter
related to the phase 4 trials of aforementioned two stents was first discussed
in the meeting of SEC, which was held on April 18, 2017. After detailed
deliberation at this meeting, the committee opined that the firm has to come up
with future plan and each patient implanted has to be systematically followed
up in a registry/phase 4 trial and protocol has to be submitted for examination
and approval.
Abbott
spokesperson did not respond to the queries sent by The Indian Express. On
February 13, the NPPA had capped the prices of coronary stents the price cap
on Absorb GT1 BVS was not kept at a higher level as requested by the company.
Interestingly, while the SEC told Abbott to conduct phase 4 trials with proper
protocols on April 18, the company told the National Pharmaceutical Pricing
Authority (NPPA) on April 21 that it wants to withdraw Absorb GT1 BVS from the
Indian market as its sale has become commercially unviable after the stent
price cap.
Five days
later, the NPPA rejected Abbott’s withdrawal application, stating that the
“statutory Form IV” attached with their “request letter” has not been “duly
signed”. On February 13, the ceiling prices of bare metal stents were fixed at
Rs 7,260 per piece and that of drug eluting and BVS stents were fixed at Rs
29,600 apiece. On March 31, the price caps were increased by NPPA to Rs 7,400
and Rs 30,180, respectively.
While rejecting
the stent withdrawal application, the NPPA added a caveat regarding one of
Abbott’s stent against which international regulators have taken action. The
pricing regulator stated in its April 26 memorandum: “However, if Abbott
Healthcare India Ltd. finds that ‘Absorb BVS’ cannot address the ‘safety
concerns’ already raised by USFDA, EU, TGA-Government of Australia, CDSCO and
others, the company can approach NPPA at any time before the period mentioned
in 5(a) above, clearly stating the reasons for withdrawal to be ‘safety
concerns’.”
The pricing
regulator also advised Abbott “to be more cautious and responsible in taking
such business decisions in the light of government’s commitment to ensure
affordability and availability of all essential drugs to the people”.
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