As the House and Senate limp toward their lame duck session with a slate full of tax cut, budget and sequestration issues, it's likely that a number of drug-related bills still sitting in committee will die with the 112th Congress.

Given all the other issues facing Congress and the November election, time is running out on many of the bills awaiting committee action. While some of the bills were introduced to make a political point and a few were addressed – to some extent, the FDA Safety and Innovation Act (FDASIA) – others attempt to answer real needs ranging from improved access to reimbursement and drug safety.

The following are among the drug-related legislative measures still pending on Capitol Hill:

• SAFE DOSES Act. Introduced last year, this bipartisan bill has a chance at passage as the House approved its version, H.R. 4223, in June. A similar bill, S. 1002, was placed on the Senate calendar this week for full Senate debate once Congress returns from its August break. The legislation would stiffen the penalties for trafficking in stolen drugs and increase the penalties for altering or falsifying the labeling or documentation of a stolen or expired drug. It is intended to deter drug theft as an organized crime.

• Cure for AIDS Act. Introduced last month, H.R. 6187 got a late start. In addition to the House Health Subcommittee, the bill was referred to the Armed Services Committee. The legislation calls for a $100 million, five-year appropriation to establish an AIDS cure research program at the Department of Defense. The program would fund research on new antiretrovirals, vaccine development and investigations into novel approaches to addressing disease progression. (See BioWorld Today, Aug. 7, 2012.)

• Compassionate Freedom of Choice Act. Another late starter, H.R. 6342 would allow the importation, distribution and sale of investigational drugs and devices intended for use by terminally ill patients. In introducing the bill earlier this month, Rep. Ron Paul (R-Texas) gave his colleagues a list of patients who, he said, "were denied access to treatments by the FDA even though their doctors believed these treatments were the only option left to potentially save their lives." The bill would require patients to sign an informed consent indicating that they are aware of potential risks. The bill was referred to the House Energy and Commerce Committee.

• National Diabetes Clinical Care Commission Act. H.R. 2960 would establish a National Diabetes Clinical Care Commission within the Department of Health and Human Services to "foster more effective implementation and coordination of clinical care for people with pre-diabetes and diabetes." Introduced last September, the House version has been awaiting action in the Health Subcommittee. The Senate version, S. 3430, was introduced last month and referred to the Health, Education, Labor and Pensions Committee.

• The Qualifying Therapeutic Discovery Project Tax Credit Extension Act. H.R. 1988 would extend the popular tax credit through fiscal 2017. Introduced in the House last year, the bill has been sitting in the Health Subcommittee. A Senate version, S. 3232, was introduced a few months ago and referred to the Finance Committee. (See BioWorld Today, May 27, 2011.)

• Stop Oxy Abuse Act. H.R. 1316 would limit the use of drugs containing controlled-release oxycodone hychloride to the relief of severe-only pain. Although the bill came up earlier this year during a House subcommittee hearing on drug diversion, it wasn't included in FDASIA. It's been sitting in the House Energy and Commerce Subcommittee on Health since April 2011 and is unlikely to pick up traction before the end of the year. (See BioWorld Today, March 5, 2012.)

• Prescription Drug Cost Reduction Act. S. 1699, introduced last October, is intended to reduce the cost of drugs under Medicare Part B. Its sponsor, Sen. Herb Kohl (D-Wis.), said the bill could have a 10-year savings of more than $140 billion. The legislation would require manufacturer rebates for Part B drugs and biologics, price negotiations when Medicare is the majority purchaser and use of the least costly alternative policy for similar drugs. It also would reduce incentives for doctors to prescribe the most expensive drugs. The bill was referred to the Senate Finance Committee. (See BioWorld Today, Oct. 17, 2011.)

• The Medicare Drug Savings Act. S. 1206 and H.R. 2190, introduced last year, would increase the discounts Medicare receives on prescription drugs for low-income individuals enrolled in Part D. The legislation would require biopharma companies with drugs covered by Part D to pay the difference between the average rebates made to private Part D drug plans and 23.1 percent of the average manufacture price. They would be subject to additional rebates if drug prices increase faster than inflation. The bill has stalled in the Finance Committee in the Senate and in the Health Subcommittee in the House. (See BioWorld Today, June 20, 2011, and July 18, 2011.)

Janssen to Pay $181M

Janssen Pharmaceuticals Inc., a Johnson & Johnson company, agreed to pay about $181 million as part of a settlement and consent decree with 36 states and the District of Columbia to resolve allegations concerning its marketing of Risperdal (risperidone).

Janssen, which didn't admit wrongdoing, said it agreed to the settlement to "avoid unnecessary expense and a prolonged legal process." As part of the settlement, it reaffirmed that it wouldn't promote its atypical antipsychotics for off-label uses or make false or misleading claims related to the drugs.

The multistate consumer fraud settlement is separate from an agreement in principle with the Department of Justice to settle three civil False Claims Act suits pending in U.S. courts. Those cases involve the sales and marketing of Natrecor, Risperdal and Invega, and allegations that the company paid kickbacks to Omnicare Inc. for purchasing and recommending Risperdal and other products. (See BioWorld Today, Jan. 25, 2010.)