Overseas dfrug and device approvals
For new drugs and devices, a faster track to market often found in Europe
Delcath Systems, a specialty pharmaceutical and medical device company, won approval for its targeted chemotherapy delivery system in Europe this year. While Delcath President and CEO Eamonn Hobbs says he expects the chemosaturation system to receive U.S. Food and Drug Administration approval in mid-2012, the company plans to move forward with plans to set up manufacturing in a yet-to-be-disclosed European country.
By hiring and installing manufacturing facilities in Europe, New York-based Delcath also is laying the groundwork for the system to be available in some growing and emerging markets, Hobbs says. The system was approved in Europe to treat tumors in the liver.
“We are going to start manufacturing in Europe in order to access emerging markets based on European approval,” Hobbs says. “Although we’re quite hopeful we’ll get (FDA) approval next year, it’s never a guarantee.”
Delcath’s story is emblematic of what advocates of the pharmaceutical and medical device industry say is the result of an increasingly unpredictable and slower approval market in the U.S.
“I’ve never seen a more difficult regulatory environment to bring new innovative technologies, both drug and device, to patients in the United States,” Hobbs says. “The risk profile of Europe is far more attractive because the regulatory process is far more predictable.”
Several studies published this year have addressed shifts in the U.S. regulatory environment, and specifically how U.S. approval rates for drugs and medical devices, as compared with those in the European Union, are faring.
The regulatory process for the drug and device market in Europe is structured differently than the U.S. system. While the FDA has oversight for drugs and devices in the U.S. market, the European Medicines Agency is responsible for drug approvals, and device companies are required to receive CE Mark approval, a standard requirement for companies in several industries to market products in 27 countries in Europe.
Other differences include the fact that reimbursement for drugs and devices is handled country by country. The device market in Europe is overseen by the Medical Devices Directive, the In-Vitro Diagnostic Directive and the Active Implantable Medical Device Directive.
A report released in February by the California Healthcare Institute, a public policy organization based in La Jolla, and the Boston Consulting Group found that from 2004 to 2006, new drugs were approved first in the U.S. by an average of about seven months. By 2007, new drugs were approved two months faster in the EU compared with the U.S.
The report also showed that high-risk medical devices, which go through a more stringent premarket approval process, are being approved almost four years earlier in Europe as compared with the process in the U.S.
“The agency-industry partnership is strained by unexplained regulatory delays, by a lack of clear standards for what clinical data are necessary for product approval, and by a bureaucracy whose communications are neither consistent nor predictable,” wrote the authors about the process in the U.S. “The flight of medical technology product launches to EU countries should be a serious cause for concern for policymakers and patient advocates alike.”
Yet, three editors at peer-reviewed medical journals and FDA officials argued that recent industry-funded reports, including the CHI report and another study conducted by researchers at Stanford University, are flawed.
They found “major problems” with both studies, including the methodologies, and questioned whether the reports should serve as the basis for policy changes to the medical device approval process, according to a House Energy and Commerce Oversight and Investigations Subcommittee memo released earlier this month.
David Gollaher, president and CEO of the California Healthcare Institute, says the FDA’s shift to become more risk-averse, along with the recent economic challenges and slowdown in the U.S. markets, have created an environment that makes it increasingly difficult for companies to pursue FDA approval.
“These factors have come together to change the business conditions for medical device companies,” he says. “There’s been an overall shift in the agency to become more and more conservative with respect to the approvals and that has slowed down the process dramatically.”
A Boston Consulting Group report stated that some “high-profile device recalls” have led to an increased focus on the approval process in the U.S. Gollaher says the FDA has become more focused on the direct risk of products and often requires more clinical data now.
As a result, companies are developing strategies to launch their products in Europe
Delcath Systems received regulatory approval in Europe
this year for its Hepatic Chemosat Delivery System, a
chemotherapy system used to treat tumors in the liver.
The company recently resubmitted its application to the FDA and hopes to receive approval