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FDA Commissioner, Gottheimer meet on ways to help biopharma industry

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From right: U.S. Rep. Josh Gottheimer, NJ-5th district; FDA Commissioner Dr. Scott Gottlieb; and Hackensack Meridian Health Co-Chief Executive Officer Dr. Robert Garrett discuss cutting red-tape for pharmaceutical and medical device companies, fighting the opioid crisis, and enhancing patient care at New Jersey hospitals.
From right: U.S. Rep. Josh Gottheimer, NJ-5th district; FDA Commissioner Dr. Scott Gottlieb; and Hackensack Meridian Health Co-Chief Executive Officer Dr. Robert Garrett discuss cutting red-tape for pharmaceutical and medical device companies, fighting the opioid crisis, and enhancing patient care at New Jersey hospitals. - ()

Cutting red tape on drug approvals and making the elimination of the medical-device tax permanent were discussed during a meeting of U.S. Food and Drug Administration Commissioner Scott Gottlieb, U.S. Rep. Josh Gottheimer, D – 5th District and health care industry executives.

Those attending the Monday meeting included Bob Garrett, co-CEO of Hackensack Meridian Health; Andrew Pecora, HMH’s chief innovation officer; and representatives of New Jersey-based biopharmaceutical companies. The press was barred from attending.

Afterwards, a person in attendance said Gottheimer promised “to work hard to completely eliminate the 2.3 percent tax on medical devices; that tax would really choke health care innovation in the state.” The tax was temporarily eliminated as part of the Affordable Care Act but was set to expire at the end of 2017 until Congress in December passed a stop-gap measure that delayed bringing the tax back for two years.

Representatives from Franklin Lakes-based Becton Dickinson and biopharmaceutical company Zimmer Biomet, based in Parsippany, also discussed with Gottlieb cutting red tape in drug approvals. The drug companies asked that the FDA consider real world data when approving new drugs, the source said. Real world data – as opposed to data derived from controlled, clinical trials – derives data from sources such as electronic health records, claims and billing data, product and disease registries and personal health applications.

“The cost of bringing new, lifesaving drugs to the market can be upwards of $1 billion,” the source said. “Placebo-based clinical trials are extremely expensive, take a long time, and are one of the big reasons why drugs are so expensive. Real world data, in some studies, has also been proven to be more effective and could help lower the cost of drugs.”

Gottheimer said in a prepared statement after the meeting: “I am proud to have the FDA Commissioner here in North Jersey, to listen to our needs and to fight for our doctors, patients, researchers, and companies. New Jersey’s seat at the table will keep jobs here, and to stop them from being sent overseas or to Moocher States.”

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Vince Calio

Vince Calio


Vince Calio covers health care and manufacturing for NJBIZ. You can contact him at vcalio@njbiz.com.

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