Life Science Compliance Update

« September 2012 | Main | November 2012 »

29 posts from October 2012

October 31, 2012

Johnson and Johnson Requests Manufacturing Permit to Reduce Shortage of Doxil

Pharmaceutical Manufacturing
Over the past year, we have written several stories about the troubling drug shortages that have been occurring.  This summer, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA), which gave FDA new authorities to help fight drug shortages.  Additionally, FDA recently announced that it had seen fewer drug shortages.   

Moving forward with positive news, Johnson & Johnson recently applied for U.S. and European regulatory approval of a new manufacturing process that would provide a short-term fix to the supply shortage of the cancer drug Doxil, reported the Wall Street Journal

Doxil is used in a variety of cancer treatments, and is among the most prominent drugs to experience a shortage situation in the US this year.  FDA has been aggressive in working to ease supply problem.  For example, in February 2012, FDA said it would allow select foreign manufacturers to import unapproved supplies of Doxil—the foreign version of which is called Lipodox—to ease shortages. 

The root of Doxil’s shortages is a “voluntary shutdown” of an Ohio facility run by Ben Venue Laboratories, a contract manufacturer working for J&J, after a November 2011 inspection by FDA and EMA found “ongoing quality and manufacturing issues,” reported RAPS.   The Doxil shortageleft as many as 2,700 patients on a waiting list for the drug last year, though J&J has since squeezed out enough supply to clear the waiting list. 

The plan includes J&J's existing contract manufacturer, Ben Venue Laboratories, whose factory troubles led to a suspension in the manufacturing and distribution of Doxil last year.  The supply crunch for the drug—used to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi's sarcoma—caused sales to plunge 87% to $37 million for the first half of 2012.  

Under J&J’s plan, Ben Venue would produce Doxil while a second supplier would handle other tasks such as ensuring the injectable drug is sterile, said J&J spokeswoman Lisa Vaga. She declined to identify the other supplier, citing “confidentiality obligations.”  FDA and EMA are reviewing J&J’s applications to use the new manufacturing process, Ms. Vaga said.  “It isn't clear when the agencies will make a decision, but J&J and Ben Venue have said they expected Doxil production to resume by the end of 2012.  Ms. Vaga said J&J is in discussions with the regulators.”  

“If regulators approve J&J's plan, Doxil would be made in areas of the Ben Venue facility that are available for production, Ms. Vaga said.”  Sterile filtration and aseptic filling—which are designed to ensure the drug remains free of contamination—would be performed elsewhere by the other supplier.  

FDA spokeswoman Erica Jefferson said the agency can't comment on any pending applications.   “We are confident using regulatory discretion to ensure the safety and utility of this product,” said FDA Associate Director Valerie Jensen, who heads the drug shortage program, at the time of the announcement.  An EMA spokesman couldn't be reached.  Doxil is sold in Europe as Caelyx. 

Ben Venue spokeswoman Marjorie Moeling said the company is making progress toward upgrading the Bedford plant. "We will provide updates on our progress to resume manufacturing once we are more fully confident that our restart plans are being realized," she said.  

In May, an EMA advisory body recommended J&J pursue a plan to transfer sterile filtration and aseptic filling for Doxil from the Ben Venue plant to an alternative site. The EMA committee recommended J&J apply for such approval by September.  

“Longer term, the New Brunswick, N.J., company is planning to move all Doxil production processes to multiple suppliers and away from Ben Venue, which plans to exit the contract-manufacturing business. That process could take about two years because of the complexity of the Doxil manufacturing process, according to the EMA.

Ms. Vaga said J&J's long-term plan is ongoing and on track.”

October 30, 2012

CMS Chooses Seven Nursing Facilities to Reduce Hospitalizations

Nursing facility residents often experience potentially avoidable inpatient hospitalizations. These hospitalizations are expensive, disruptive, and disorienting for frail elders and people with disabilities.  Nursing facility residents are especially vulnerable to the risks that accompany hospital stays and transitions between nursing facilities and hospitals, including medication errors and hospital-acquired infections. 

Many nursing facility residents are enrolled in both the Medicare and Medicaid programs (Medicare-Medicaid enrollees).  The Centers for Medicare and Medicaid Services (CMS) research on Medicare-Medicaid enrollees in nursing facilities found that approximately 45% of hospital admissions among those receiving either Medicare skilled nursing facility services or Medicaid nursing facility services could have been avoided, accounting for 314,000 potentially avoidable hospitalizations and $2.6 billion in Medicare expenditures in 2005. 

To address these concerns, CMS recently announced 7 healthcare entities that will take part in a new initiative, known as the “Initiative to Reduce Avoidable Hospitalizations among Nursing Facility Residents.”  This new effort aims to improve the quality of care for people residing in nursing facilities. 

First announced back in March 2012, the initiative will allow CMS to partner with the seven organizations to implement strategies to reduce avoidable hospitalizations for Medicare-Medicaid enrollees who are long-stay residents of nursing facilities.  The Initiative directly supports CMS’ ongoing work to reduce avoidable hospitalizations for Medicare-Medicaid enrollees.  The organizations include: 

  • Alabama Quality Assurance Foundation – Alabama Read More
  • Alegent Health – Nebraska Read More
  • HealthInsight of Nevada – Nevada Read More
  • Indiana University – Indiana Read More
  • The Curators of the University of Missouri – Missouri Read More
  • The Greater New York Hospital Foundation, Inc. – New York City Read More
  • UPMC Community Provider Services - Pennsylvania Read More 

The initiative will allow organizations to implement evidence-based interventions that reduce avoidable hospitalizations.  The enhanced care & coordination providers will collaborate with States and nursing facilities, with each enhanced care & coordination provider implementing its intervention in at least 15 partnering nursing facilities.

The goal of this Initiative is to:  

  • Reduce the number of and frequency of avoidable hospital admissions and readmissions;
  • Improve beneficiary health outcomes;
  • Provide better transition of care for beneficiaries between inpatient hospitals and nursing facilities; and
  • Promote better care at lower costs while preserving access to beneficiary care and providers.

Participants in the model – called “enhanced care and coordination providers” –will implement and operate their proposed interventions over a 4-year period.  Each participant is required to partner with a minimum of 15 Medicare-Medicaid certified nursing facilities in the same State where the intervention will be implemented. Nursing facility participation is voluntary.  

Participants proposed evidence-based interventions to accomplish the goals of the initiative in their applications to CMS.  The Initiative did not prescribe a specific clinical model for these interventions.  However, all proposed interventions must:  

  • Improve beneficiary safety by better coordinating management of prescription drugs to reduce risk of polypharmacy and adverse drug events for residents, including inappropriate prescribing of psychotropic drugs.
  • Bring onsite staff to collaborate and coordinate with existing providers, including residents’ primary care providers and the staff of the nursing facility. 
  • Demonstrate a strong evidence base for the proposed intervention and potential for replication and sustainability in other communities and institutions across the country.
  • Supplement (rather than replace) existing care provided by nursing facility staff.
  • Allow for participation by nursing facility residents without any need for residents or their families to change providers or enroll in a health plan. Residents will be able to opt-out from participating, if they choose.

 CMS estimates that upon implementation, the awarded interventions will reach more than 17,000 beneficiaries over the four years of the Initiative.


Preview | Powered by FeedBlitz


October 2015
Sun Mon Tue Wed Thu Fri Sat
1 2 3
4 5 6 7 8 9 10
11 12 13 14 15 16 17
18 19 20 21 22 23 24
25 26 27 28 29 30 31