(May 19, 2019 / JNS) This week the United States commemorated the one-year anniversary of the transfer of its embassy from Tel Aviv to Jerusalem. More than two decades in the making, finally, the move was accomplished. Unafraid to rock the boat and take a fresh look at many issues in the Middle East, the Trump administration has implemented many policies which have long seemed logical, yet due to political considerations, among other issues, were never carried out.
Among these are recognition of the Israeli sovereignty over the Golan Heights, recognition of Jerusalem as the capital of Israel, reassessment of American contributions to UNRWA, closing the PLO mission in Washington and more.
American and Israeli officials have commented that joint cooperation between the two countries is at a record high, and that never has the general relationship been this close. Another area of potential joint cooperation between America and Israel would be a partnership between the U.S. Food and Drug Administration (FDA) and the Israeli Health Ministry in the form of a U.S. FDA global office in Israel.
Israel is a global leader in the development of groundbreaking pharmaceuticals, medical devices and nutritional products that have made a substantial impact on global health and well-being. There is virtually no area of medicine to which Israeli devices have not made significant contributions—cardiology, genetics, neurology and ophthalmology are but a few of the medical fields benefiting from advanced Israeli technology. Israeli scientists, universities and companies are working to benefit the global health system—from physician to patient to medical administrators and insurers.
The FDA has broad authority over the way new medical and food products are developed, manufactured, marketed and distributed globally. The FDA strongly encourages companies to communicate early and often with the FDA on their approach and progress. As a result, the FDA has set up partnerships and established offices in China, India, Europe and Latin America to share and provide regulatory information. The FDA also cooperates with academic institutions and private companies in foreign markets to improve communication with companies that seek FDA guidance in submitting their products for regulatory review.
An FDA office in Israel would have tremendous benefits for Israeli companies, such as early interactions/negotiations with the FDA; obtaining regulatory insight; identifying and avoiding unnecessary studies and making sure that necessary studies are designed to provide useful information, all of which would save Israeli companies valuable time and money, as well as minimizing risk to investors both in Israel and abroad. It could also to lead to closer cooperation between the Israeli Health Ministry and the FDA, leading to potential partnership opportunities such as third-party accredited sites, Israel being a part of the Medical Device Single Audit Program (MDSAP) and more.
The United States would also benefit from such a partnership as the FDA would be able to partner with Israel private sector in tech transfers and to address regulatory science and other U.S. domestic challenges in food and drug safety. It would also provide an opportunity for an ongoing exchange of ideas; create pathways for private-sector cooperation between American and Israeli companies in FDA-regulated fields, and it would help Israeli products of interest to the United States reach its markets quicker.
About a decade ago, the United States began opening up FDA global offices in strategic points across the world. While the general modus operandi of these global offices is to facilitate collaborations to streamline and enhance global drug development and regulation; gather information on local products being transported to U.S. ports; and assist in strengthening the regulatory systems of the FDA’s foreign counterparts; the sky is the limit in terms of potential collaboration, and that can largely depend on the host country and the partnership it seeks.
American-Israel cooperation has reached many heights in the many areas of collaboration between the two countries. This is due to the mutual benefits of such collaboration and the creativity of those involved to make sure the maximum is gained. A U.S. FDA office is another area where the United States and Israel can join together for the mutual benefit of both countries.
Gideon Israel is the director of the Jerusalem Washington Center, which works to strengthen the U.S.-Israel relationship through mutually beneficial policy projects.