Dr. Miller s cri de coeur is well-earned: he was the founding director of the FDA s Office of Biotechnology (too bad he decided to revert to the private sector, now with the Hoover Institution at Stanford). He points out that, although pharmaceutical biotechnology has largely evaded the cold dead hand of hyper-regulation (think of insulin, e.g., marketed in 1982, and such products now account for over one-fifth of U.S. drug expenditures), in other sectors genetic engineering has failed to realize anything approaching its potential for vertical progress. (Vertical progress involves imagining and creating the groundbreaking, disruptive technologies, true advances; while horizontal progress means making more of the same, or similar).
Dr. Miller tells it like it is when seeking whom to blame for this frozen in place approach to intensive advances: The reason is plain: In the non-pharmaceutical sectors, federal regulators for years seemingly have done everything they can to prevent U.S. researchers and companies from employing genetic engineering to create the next big thing.
While the White House Office of Science and Technology Policy (OSTP) s official policy was, and remains, that regulatory stringency should not be process- or method-related, but risk-related, the EPA and USDA created in the 1990s a veritable thicket of regulatory barriers focused on the genetic-engineering technology itself, the most precise and least-risky method of agricultural breeding. The result? Predictable: multi-million dollar disincentives have quashed this once-promising technology.
Biopharming the once-promising biotechnology area that uses genetic engineering techniques to induce crops such as corn, tomatoes and tobacco to produce high concentrations of high-value pharmaceuticals (one of which is the Ebola drug, ZMapp) is moribund because of the Agriculture Department s extraordinary regulatory burdens. Thanks to EPA s policies, which discriminate against organisms modified with the most precise and predictable techniques, the high hopes for genetically engineered biorational microbial pesticides and microorganisms to clean up toxic wastes have evaporated.
As a result, the potential for vertical progress for innovation that modern genetic engineering holds for long-term, robust U.S. economic growth and higher living standards has been drastically reduced.
The situation in Europe for GMO crops is, if anything, even worse. Last year, the Council and Parliament delegations in the EU voted to allow individual countries to ban growth of GE crops, but only on their own territory, even if the growing of these crops is allowed at the EU level. This proposal is now due to become a law, with the backing of the European Parliament. However, this law is actually a stop sign for innovation in Europe, according to the European Association for BioIndustries, EuropaBio.
Jeff Rowe, chairman of the Agri-Food Council of EuropaBio says, Member states will receive a license to ban safe products which have been approved at European level, and they will be allowed to base these bans on non-scientific grounds ¦European researchers and farmers have lost access to this key-enabling technology and the chance to grow more sustainable crops and remain globally competitive.