Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014
Latest action. Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014 - Amends the Controlled Substances Act to direct the Attorney General, within 45 days of receiving a recommendation from the Secretary of Health and Human Services (HHS) to add a drug or substance that has never been marketed in the United States to a schedule of controlled substances, to issue an interim final rule under the exception for good cause, placing it into the schedule recommended, effective immediately.
Allows a person who submits an application for registration to manufacture or distribute a controlled substance to indicate on the registration application that the substance will be used only in connection with clinical trials of a drug. Requires the Attorney General to: (1) make a final decision on such application within 180 days, or (2) provide written notice to the applicant of the outstanding issues that must be resolved to reach a final decision and the estimated date on which such decision will be made.
Defines: (1) "factors as may be relevant to and consistent with the public health and safety," and (2) "imminent danger to the public health or safety."
Requires an order to show cause as to why a registration should not be denied, revoked, or suspended to notify the registrant of the opportunity to submit a corrective action plan on or before the date of appearance before the Attorney General. Requires the Attorney General, upon review of any such plan, to determine whether denial, revocation, or suspension proceedings should be discontinued or deferred for purposes of modification or clarification of such plan. Makes these requirements inapplicable to the issuance of an immediate suspension order.
Directs the Secretary, acting through the Commissioner of Food and Drugs (FDA) and the Director of the Centers for Disease Control and Prevention (CDC), to identify: (1) obstacles to legitimate patient access to controlled substances; (2) issues with diversion of controlled substances; and (3) how collaboration between federal, state, local, and tribal law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances.
Written by analysts at the Congressional Research Service and published on Congress.gov, not by Civibrief. Summarized at the "Introduced in Senate" stage on September 18, 2014. It describes the bill, it is not the legal text.
Where is it in the process, and what happens next?
4 steps remain before this bill could become law.
The record's latest action, on September 18, 2014: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Clearing the committees it was referred to, and being scheduled for a floor vote
- Passage by the Senate
- Passage by the House
- The President's signature. If the President vetoes it, two-thirds of both chambers must vote to override.
How likely is it to become law?
Civibrief does not forecast outcomes and this page has no opinion about this one. What the record supports is a base rate, which is a fact about the whole pile, not a prediction about this measure.
In the 113th Congress (2013-14), 296 of the 9,091 bills and joint resolutions introduced became law, about 3.3 percent. That count covers every measure at every stage, including the many that never left committee.
This one is not there yet: 4 steps are still outstanding, listed above.
Has anyone actually voted on it?
No. No roll call in this Congress cites this measure. That is the ordinary outcome: most measures never reach a recorded floor vote, and a committee ends most of them simply by not acting.
A vote is not the only thing that happens to a measure. Hearings, markups, and referrals are all recorded actions, and none of them is a vote of the full chamber.
Who is behind it?
ORRIN HATCH (R-UT) introduced it on September 18, 2014, and 2 members have since signed on as cosponsors.
They come from both major parties: 1 Democrat, 1 Republican.
Cosponsoring is a formal signature on the text. It is not a commitment to vote for the measure, it does not bind anyone's party, and a long list of cosponsors is a measure of attention rather than of prospects.
How long has it been in play?
It was introduced on September 18, 2014, 4375 days ago. The most recent recorded action was 4375 days ago, on September 18, 2014.
Measures do not carry over. Anything the 113th Congress has not finished by January 3, 2015 dies when the term ends, and has to be introduced again from the start in the next Congress.
Every answer above is assembled from this measure's own record on Congress.gov and from published counts of what Congress has passed before. Civibrief does not predict outcomes and takes no position on any measure.
Vote history
- SenateIn committee, no floor vote yet
- HouseAwaits Senate passage
- PresidentAwaits both chambers