Meeting the need for speed
WASHINGTON, D.C.—In concert with the Biotechnology Industry Organization (BIO), North Carolina Democratic Senator Kay Hagan has crafted draft legislative language that both political parties hope will streamline and better organize the way that potential drugs come to market.
The proposal is known as TREAT, an acronym for Transforming the Regulatory Environment to Accelerate Access to Treatments.
Tentative plans being crafted by Senator Hagan and BIO would permit manufacturers such as GlaxoSmithKline PLC (GSK), which has a significant presence in Hagan’s home state, to leap customary clinical trial hurdles before bringing products to market. The draft proposes allowing approval of some drugs after successfully completing two of the usual three phases of clinical trials.
“GSK appreciates Senator Hagan’s ongoing interest in fostering patients’ access to new and innovative therapies,” Melinda Stubbee, a GSK spokeswoman, tells ddn. “We are in the process of reviewing the draft legislative language.”
Specifically mentioned are classes of drugs to address AIDS and cancer. Also identified by Congressional definition are a class of diseases known as “orphan diseases,” which are classified as rare disorders affecting fewer than 200,000 patients in the United States. With more than 6,000 of these conditions identified, these afflictions impact millions of Americans. In the past five years, the U.S. Food and Drug Administration (FDA) has approved approximately 85 rare-disease therapies.
In the current regulatory environment, exemptions to the three-trial rule are occasionally permitted under decades-old rules, and the criteria used are termed by the industry as “unclear and unpredictable.” Accelerated approval allows the shorter trials to prove a measured effect of a trial therapy, in place of a clinical outcome. After the fact, the drug company must prove that the drug is effective. Physicians may also assist patients in gaining access to medications that they feel will benefit a patient.
The legislation provides that if a drug were approved for use in other countries, this would carry significant weight in approving drugs quickly in the United States. In addition, the draft legislation addresses a possible overhaul of the fee system pharmaceutical companies use to fund FDA reviews. Discussions between the FDA and the drug industry have leaned toward a 6-percent fee increase as part of a plan that extends to 2017.
The legislation would also enable the creation of an internal management review board at the FDA, which would be intended to increase the efficiency of the agency. Twenty-two individuals would be appointed to the board, with some members coming from within the agency. The biotech, drug, food and medical device industries would also be represented.
The appointment of a chief innovation officer would also become a reality if TREAT becomes law. It would also set in stone the term of the FDA commissioner at six years, but not limit reappointments of that individual to additional terms.
Hagan’s office and BIO representatives did not return calls for comment for this story.