During the course of the 112th Congress, there was a good deal of legislation introduced that, if passed, would impact either the pharmaceutical industry or FDA itself. Much of that legislation did not pass but some of it has found a new home in the ranks of proposed legislation in the 113th Congress – and some of it is looking strikingly similar.
Below is a partial listing of proposed bills that would affect either the way FDA or industry does business. Some of the bills focus on issues of abuse of opioids, increased access to prescription drugs, costs or even the marketing of drugs (with a proposal to cut the business deduction for DTC).
As new bills affecting FDA or industry are introduced, they will be included on this list which is housed on a tab entitled “Proposed Federal Legislation – 113th Congress” located on the main Eye on FDA landing page. (Also on the tab are some resources to help you track current proposed legislation and research past efforts.)
- H.R.413-To eliminate the 2-year delay in including oral-only ESRD-related drugs in the Medicare ESRD prospective payment system, as provided under section 632(b)(1) of the American Taxpayer Relief Act of 2012.
– Link to Sponsor Peter Welch Release on the Bill.
- H.R.460 – Patients’ Access to Treatments Act of 2013 – Establishes cost-sharing limits for health plans that cover prescription drugs and use a formulary or other tiered cost-sharing structure.
- H.R.486 – Stop Tampering of Prescription Pills Act of 2013 – Requires FDA to prescribe new drug application requirements for abuse-deterrent drugs that (1) contain an opiate, (2) are oral, (3) have properties that lend themselves to abuse/misuse, and (4) contain one or more additional ingredients intended to deter abuse through pharmacological effects.
- H.R.672 – Prescription Drug Abuse Prevention and Treatment Act of 2013 – Provides for award grants Buy Viagra to states and non-profits for consumer education about opiod abuse, including methadone abuse and puts into place new training requirements for practitioners.
- H.R.923 – Say No to Drug Ads Act – This would eliminate any tax deduction for the cost of direct-to-consumer advertisting for prescription drugs.
- H.R.928 –Medicare Prescription Drug Savings and Choice Act of 2013 – Aims to lower prescription drug prices through directing HHS to negotiate prices with industry, to establish a formulary and to encourage the use of a formulary and formulary practices.
- H.R.1024 – Medication Therapy Management Empowerment Act of 2013 -Amends Part D to provide access to services under medication therapy management programs for Part D eligible individuals with a single chronic disease.
- S.77 – Prescription Drug and Health Improvement Act of 2013 – Repeals prohibition against interference by HHS Secretary with negotiations between drug manufacturers and pharmacies and prescription drug plan sponsors, and requires a particular formulary or instituting price structure for the reimbursement of covered part D drugs.
- S.117 – Medicare Prescription Drug Price Negotiation Act of 2013 – This bill would direct the HHS Secretary to negotiate prices for drugs under the Medicare Part D Prescription Drug Program.
- S.214 – Preserve Access to Affordable Generics Act – Would permit the FTC to initiate a proceeding against parties to any agreement that resolves or settles a patent infringement claim in connection with the sale of a drug.
- S.348 – Prescription Drug Abuse Prevention Act of 2013 – Puts into place training requirements for prescribers of methadone or other opioids and to require each registered opioid treatment clinic to make arrangements for each patient who is restricted from having a take-home dose to receive a dose under supervision when the clinic is closed. (Related to H.R.672)
- S.408 – Medicare Prescription Drug Savings and Choice Act – Related to H.R.928.