Congressman Joe Pitts (PA-16) chaired a hearing of the Energy and Commerce Health Subcommittee to discuss several bills, including his own H.R. 4299, the Improving Regulatory Transparency for New Medical Therapies Act. This bipartisan legislation seeks to improve the transparency and consistency of Drug Enforcement Agency review of pharmaceuticals.
"It now takes, on average, well over a billion dollars and 14 years from the time a drug is discovered to the time of approval," said Pitts. "A lack of predictability in the timing of DEA scheduling decisions leads to unnecessary uncertainty in the drug development process and needless delays in patients' access to new therapies."
Patient groups, including the Epilepsy Foundation, support the bill. Dr. Nathan Fountain, the chair of the group's medical advisory board, testified on behalf of the foundation.
"This bill is a simple solution to the problem and will ensure that drugs will not sit around waiting to be scheduled and patients won't be forced to wait on potentially life-changing drugs," said Dr. Fountain. "H.R. 4299 will allow more innovative treatments to reach the market and give a clear timeline for drug availability from FDA through DEA."
The Ranking Member of the Health Subcommittee, Congressman Frank Pallone (D-NJ), is the Democratic lead sponsor of the bill.
"In recent years, this Committee has worked successfully to approve the review of new medications," said Pallone. "Without weakening FDA oversight, we've given manufacturers and patients groups a more predictable process, allowing patients to get timely access to the latest innovations and therapies available. But unfortunately, when a medicine has abuse potential the DEA's authorities under the Controlled Substances Act are hindering this progress."