Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. CBO scores Senate’s FDA user fees bill
The Congressional Budget Office last week scored a U.S. Senate bill to re-up the user fee agreement between the medical device and pharmaceutical industries, saying it would add $740 million to the budget and a negligible amount to the deficit over 2017 to 2022.
The “FDA Reauthorization Act of 2017” would see medical device companies put up a collective $1 billion in user fees, which pharma firms putting up another $8 billion for drug reviews, the budget office estimated. That money, the fees companies pay to have the federal safety watchdog review their products, would offset most of the increase in net discretionary spending, according to the CBO. The bill would raise direct spending by $13 million and lower revenues by $2 million from 2017 to 2022 but raise the total deficit by a paltry $15 million from 2017 to 2027, the CBO estimated. Read more
4. Staar Surgical settles shareholder class action suit for $7m
Staar Surgical has reached a $7 million settlement deal to end an investor suit claiming that the company concealed problems at its California plant which resulted in an FDA warning letter, according to court documents posted this week.
The company reached the settlement with the certified class of investors after 3 years of litigation, according to court documents from the US District Court of the Central District of California. Read more
3. J&J, Medtronic push back against TGA priority review proposal
Johnson & Johnson and Medtronic are pushing back against the Australian Therapeutic Goods Administration’s proposed priority review pathway for medical devices, citing faults in the proposal that they claim will keep them from using it, according to a RAPS report.
The major medtech players said they had doubts whether the pathway, designed to hasten approval, would actually cut time to get medical devices to patients in the region. The companies also voiced concerns that the pathway could negatively impact new and breakthrough devices, according to the report. Read more
2. Medtronic wins reprieve in ‘free services’ false claims suit
A federal judge in Pennsylvania this week dismissed with leave to amend False Claims Act allegations suggesting Medtronic offered free services and support to customers to entice them to buy its medical devices on grounds that the suit did not clearly identify how the support services crossed the line and acted as kickbacks.
The claims allege that Medtronic “paid healthcare providers illegal kickbacks in the form of free services and staff to induce providers to choose the defendant’s products over those of its competitors,” according to court documents. Read more
1. Zimmer Biomet cleaned house after FDA inspection at Warsaw plant
Zimmer Biomet told the FDA that it cleaned house after the federal safety watchdog’s inspection last year turned up numerous violations at a plant in Warsaw, Ind., replacing 5 operations and quality executives as it sought to bring the facility back into compliance.
The FDA inspected the North Campus location in Warsaw just before Thanksgiving last year and documented numerous violations in a Form 483. The company replied Dec. 21, 2016, with a lengthy account detailing its actions in remediating the problem, noting that company-wide audits put in place after the $14 billion merger of Zimmer and Biomet had already turned up problems at the site. Read more
