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On July 15, 2015, the House of Representatives approved by voice vote the following two bills...

On May 5, 2015, the Senate approved the conference report to accompany S.Con.Res. 11, the concurrent resolution setting forth the federal budget for FY 2016 and establishing budgetary target levels for FYs 2017 through 2025, ..

The Senate Appropriations Committee has scheduled a May 7, 2014 hearing to review the Administration’s FY 2015 budget request for the HHS.

A House Ways and Means Subcommittee on Oversight hearing recently reviewed the effects of the Affordable Care Act (ACA) on health insurance premiums.

On October 16, 2013, the House and Senate approved H.R. 2775, the Continuing Appropriations Act of 2014. Under the resolution, the federal government was reopened, after being closed since October 1, 2013.

The DOJ notes that 669 qui tam suits were filed this past year.

The Department of Justice (DOJ) recently announced that it recovered $3.8 billion in settlements and judgments in civil False Claims Act cases in fiscal year (FY) 2013, including health care fraud recoveries totaling approximately $2.6 billion.

In a post on our Life Sciences Legal Update blog here, we discuss the first judicial opinion interpreting the Affordable Care Act's "60-Day Overpayment Rule" in a False Claims Act case...

On November 18, 2015, the House Energy and Commerce Committee approved several public health policy bills.

As mentioned on our Health Industry Washington Watch blog, the U.S. Food and Drug Administration (FDA) has announced a plan intended to incentivize manufacturers to voluntarily update their prescription drug and biologics labels.

FDA and CMS have announced that they are establishing an interagency task force to reinforce their collaboration regarding the oversight of laboratory-developed tests.

As mentioned on our Health Industry Washington Watch blog, the Food and Drug Administration issued a final guidance document on January 16, 2014 which provides specific recommendations on the content and format of Dear Health Care Provider (DHCP or "Dear Doctor") letters.

On September 5, 2014, the FDA is holding a public meeting at the Washington Plaza Hotel, in Washington DC, to discuss current scientific and regulatory approaches to biomarker development, acceptance, and utility in the development of therapeutic products (e.g., drugs and biologics).

As reported on our Life Sciences Legal Update blog, the FDA has issued draft guidance addressing the unique challenges of drug promotion in the age of social media.

The FDA announced that it will be holding a public 2-day workshop on September 29-30, 2015, from 8:00 a.m. to 5:00 p.m. titled, "Medical Device Patient Labeling."

On November 9 and 10, 2016, the Food and Drug Administration (FDA) is hosting a public hearing on "Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products."

As discussed on our sister blog, Life Sciences Legal Update, the FDA has published a notice soliciting comments on a draft guidance document on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products.