Wednesday, October 13, 2013
ObamaCare Implementation: The Rollout of Healthcare.gov
House Oversight and Government Reform Committee Hearing
2154 Rayburn House Office Building
Cyber Side-Effects: How Secure is the Personal Information Entered into the Flawed Healthcare.gov?
House Homeland Security Committee Hearing
311 Cannon House Office Building
Budget Conference Committee Meeting
1100 Longworth House Office Building
Thursday, October 14, 2013
The Effects of the Patient Protection and Affordable Care Act on Schools, Colleges, and Universities
House Education and the Workforce Committee Hearing
2175 Rayburn House Office Building
Obamacare Implementation Problems: More than Just a Broken Website
House Energy and Commerce Subcommittee on Health Hearing
2322 Rayburn House Office Building
Self-Insurance and Health Benefits: An Affordable Option for Small Business?
House Small Business Subcommittee on Health and Technology Hearing
2360 Rayburn House Office Building
Friday, November 15, 2013
Reviewing FDA’s Implementation of FDASIA
House Energy and Commerce Subcommittee on Health Hearing
2322 Rayburn House Office Building
Yesterday, the House passed the latest in the series of limited funding bills, voting to fund the Food and Drug Administration (FDA) at post-sequestration levels. This resolution was approved by a vote of 235-162.
It was also reported yesterday that the Centers for Disease Control and Prevention (CDC) may begin recalling some of its employees to work. CDC has been operating with 32 percent of its staff for the last week. This announcement comes after the FDA issued a public health alert regarding a salmonella outbreak on the West Coast.
A week into the federal government shutdown, the latest Washington Post-ABC News poll finds that 51% Americans disapprove of how President Obama is handling the budget negotiations while 45% approve, a slight improvement from the last week in September (41% approve to 50% disapprove). Americans also overwhelmingly disapprove of how both Congressional Democrats (61% disapprove) and Republicans (70% disapprove) are handling the negotiations.
An article by Drinker Biddle’s Lobbying and Advocacy Team member Anna Howard was recently published in the Pharmaceutical Compliance Monitor. Anna coauthored the article with Sally White, an associate in Drinker Biddle’s Products Liability Group. The article, “The Next Four Years: A Prescription for Change,” discusses new challenges and opportunities for the pharmaceutical industry, including the establishment of health insurance exchanges, development of a new pathway for biosimiliars, and fiscal issues, among others.
Yesterday, by a vote of 387-5, the House approved its version of the Food and Drug Administration (FDA) User Fee Act (H.R. 5651). Representatives Amash (R-MI-3), Hinchey (D-NY-22), Labrador (R-ID-1), McClintock (R-CA-4), and Paul (R-TX-14) voted against the legislation.
The legislation will reauthorize the Prescription Drug User Fee Act and Medical Device User Fee Act, as well as authorize the Generic Drug and Biosimilar User Fee Acts. In addition, the legislation reauthorizes the Best Pharmaceuticals for Children Act and the Pediatric Equity Act; contains certain FDA administrative reforms; provides for changes in the regulation of medical devices and prescription drugs; and, provides for additional reporting and other provisions which attempt to address the problem of prescription drug shortages.
The Congressional Budget Office (CBO) estimated the legislation would reduce the deficit by $370 million over the next ten years.
The Senate passed its version of the User Fee Act on May 24th. The House and Senate will now conference these bills to reconcile any differences between the House and Senate versions. Final legislation is expected to be enacted before the August recess.
By a final vote of 96 to 1 (Senator Sanders being the sole “no” vote), the Senate passed the FDA bill (S. 3187). The House is expected to take up the measure when it returns from its Memorial Day recess.
Prior to passage a variety of amendments were considered by the Senate. (Please visit our blog post from earlier today for links to each of these specific amendment.) Amendments agreed to by unanimous consent include:
- Cardin #2125, ensuring adequate information regarding the health benefits and risks of medical products for all populations.
- Cardin #2141, providing for an FDA report on small business.
- Grassley #2121, providing additional whistleblower protections.
- Grassley #2129 providing for a GAO report on clinical trial registries and reporting requirements.
- Manchin #2151 (as modified) reclassifying hydrocodone under the Controlled Substances Act.
- Reed #2126 , changing the compliance date for rule related to sunscreen products.
- Leahy #2142, exempting from the Freedom of Information Act (FOIA) information relating to drug inspections obtained from a foreign government agency.
- Portman #2145 (as modified) enacting the Interstate Drug Monitoring Efficiency and Data Sharing Act.
- Coburn #2131 providing for an independent assessment of the drug application review process.
The Portman amendment #2146 (as modified) (which would enact the “Synthetic Drug Abuse Prevention Act”) was agreed to by a voice vote.
The Coburn amendment #2132 (which would tie a portion of FDA employee performance standards to their User Fee Act goals) was withdrawn. The Paul amendment (#2143) and Durbin amendment (#2127) were tabled.
The Senate voted on the following amendments:
- Bingaman #2111, changing the 180-day exclusivity period for generic drugs to allow greater generic drug market entry, was defeated by a vote of 67-28.
- Murkowski #2108, seeking to prevent the approval of applications for genetically engineered fish, failed by a vote of 46-50.
- McCain #2107, allowing individuals to import prescription drugs from Canada, failed by a vote of 43-54.
- Sanders #2109, limiting prescription drug exclusivity for companies convicted of fraudulent activities, failed by a vote of 9-88.
Yesterday, Senators announced an agreement has been reached to limit amendments on S. 3187, the FDA bill. The underlying legislation reauthorizes the Prescription Drug User Fee Act and Medical Device User Fee Act, and authorizes the Generic Drug User Fee Act and Biosimilar User Fee Act. In addition, the legislation: (1) encourages additional research for pediatric drugs and devices; (2) provides for medical device regulatory improvements; (3) changes to the drug supply chain; (4) creates incentives for research and development for antibiotics; (5) provides additional reporting requirements to prevent drug shortages; and, (6) contains additional provisions. Legislative information can be found here and the CBO score released on May 22nd can be found here.
Under the agreement, only the following amendments are deemed to be in order:
- Bingaman #2111 (generic drug market entry);
- McCain #2107 (importation of prescription drugs from Canada);
- Sanders #2109 (limits exclusivity in cases of criminal fraud);
- Murkowski #2108 (genetically engineered fish);
- Cardin #2125 (communications plan on health benefits and risks of medical products);
- Cardin #2141 (FDA report on small business);
- Grassley #2121 (provides additional whistleblower protections);
- Grassley #2129 (GAO report on clinical trial registries and reporting requirements);
- Manchin #2151, as modified (reclassifying hydrocodone under CSA);
- Portman #2146, as modified (“Synthetic Drug Abuse Prevention Act”);
- Portman #2145, as modified (“Interstate Drug Monitoring Efficiency and Data Sharing Act”);
- Reed #2126 (changes compliance date for rule related to sunscreen products);
- Coburn #2132 (ties a portion of FDA employee performance standards to their User Fee Act goals);
- Coburn #2131 (independent assessment of the drug application review process);
- Durbin #2127 (dietary supplements registration requirements);
- Paul #2143 (supplements); and
- Burr #2130 (transparency in user fee negotiations).
Debate for all amendments will be limited to 30 minutes for each amendment equally divided (with the exception of the McCain importation amendment for which there will be 1 hour on each side for debate). Debate for the underlying legislation is limited to 60 minutes, equally divided.
Today (May 24th) at approximately 2 pm, the Senate is scheduled to begin voting on the amendments. Most of the amendments will require a simple majority; though the following amendments will be subject to a 60 vote threshold: Bingaman #2111 (generic filings); McCain #2107 (reimportation); Sanders #2109 (limits exclusivity in cases of criminal fraud); and Murkowski #2108 (genetically engineered fish).
There are some new requirement for clinical trials that take effect this week. For applicable clinical trials regulated by the U.S. Food and Drug Administration (FDA) that are initiated on or after March 7, 2012, sponsors, investigators and institutional review boards will have to assure compliance with an additional informed consent requirement. For more information click here for a great alert done by our colleagues.
The Food and Drug Administration (FDA) released in the Federal Register three draft guidances on biosimilar products today. The Affordable Care Act, or health reform law, included the Biologics Price Competition and Innovation Act, which, according to the FDA, “creates an abbreviated licensure pathway for biological products that are demonstrated to be ‘biosimilar’ to or ‘interchangeable’ with an FDA-licensed biological product.” Biosimilar products have no “clinically meaningful” differences from their reference product and produce the same clinical result with no reduced safety or efficacy risks, even when switching between the two products. In addition to creating a streamlined process for licensure of biosimilars, the Biologics Price Competition and Innovation Act adds proteins to the definition of a biological product. As such, proteins, with the exception of chemically synthesized polypeptides, will be regulated as biological products.
The three draft guidance documents are available on the FDA website:
1. Scientific Considerations in Demonstrating Biosimiliarity to a Reference Product (Docket Number FDA–2011–D–0605)
2. Quality Considerations in Demonstrating Biosimiliarity to a Reference Protein Product (Docket Number FDA-2011-D-0602):
3. Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (Docket Number ):
Comments on these guidance documents may be submitted in writing or electronically at http://www.regulations.gov. The comment period will remain open for 60 days, until Monday, April 16, 2012.
Additional information on FDA’s biosimilars development and approval process, including a recording of February 15th Webinar on the draft guidance, is available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDeveloped-andApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/default.htm.
As Congress plays beat the clock, most people already have 2011 in the rear-view mirror and are looking to 2012, trying to discern what the Congress will do – or not – with respect to health care. With the November 6th election as the finish line, there are 311 calendar days and many fewer “legislative” days for Congress to meet and do any work. Factoring in scheduled recesses and adding in Mondays and Fridays, which Congress typically uses for “district work periods,” there are an estimated 109 actual days that Representatives and Senators will be in D.C. So, how will they use this precious time? Continue reading