Inexplicable Delays by DEA Regulators Imperil Only Known Test for Parkinson's

Terry Mahn, managing principal at Fish & Richardson P.C. in Washington, said that for the past 30 years, one of the ironclad tenets of the Hatch-Waxman Act is the right to five years of data exclusivity for FDA-approved new chemical entities.

"This valuable 'property right’ was, and is still is, considered essential to incentivize manufacturers to invest in the discovery and development of new drugs," Mahn said in an e-mail. "Thus, it comes as a great disappointment to many to witness two important federal agencies seeming to work at cross-purposes when they should be working for the common good," he said.