Woodcock addresses the Senate about biosimilars

As FDA begins to build policy and review biosimilar submission packages, the Senate subcommittee on Primary Health and Retirement Security shows some skepticism about the time delay and difficulties that have emerged. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), responded by addressing the importance of getting the science right for the release of the first biosimilars. Read her testimony on fda.gov from September 17, 2015 here. When asked about the education of biosimilars to medical professionals, she said that they’ve “laid out a plan of education campaigns and still need to determine what people need to know.” To read more in an article on raps.org, click here.

New FDA commissioner nominated by Obama

Since Commissioner Margaret Hamburg resigned in March, it has been speculated that Robert Califf could be the new US FDA commissioner. Califf has been with FDA since February in the role as depute commissioner for medical products and tobacco.

Going forward along with this new change, the Senate is currently working toward legislation to expedite FDA drug approval process. To read Zachary Brennan’s complete article, click here. Also check out the article in Medscape.

FDA’s final rule to allow destruction of drugs

FDA has enforced a final rule that allows the destruction of a drug that has been denied entry into the US. The final rule will help control the unwanted drugs that are illegally snuck into the US. Brennan states  that the preexisting rule remains the same that the “owner or consignee of a drug valued over the current $2,500 threshold that has been refused admission will still have the option to destroy or export that drug.” The final rule provides additional structure that “for a drug valued at $2,500 or less that has been refused admission, FDA is allowed to destroy the drug without providing the owner or consignee with the opportunity to destroy or export it.”

It is estimated that the final rule will cause approximately 15,100 destructions each year and will save $901,950 annually. The final rule will take effect on October 14th. To learn more, check out Zachary Brennan’s article on RAPS.org.

FDA makes changes to dispute resolution guidance

FDA has updated its guidance on resolving disagreements and disputes between sponsors and the agency. The goal is to avoid messy disputes by holding discussions that will hopefully lead to more timely resolutions. The revisions of the guidance state more appropriate regulatory actions for a formal dispute resolution request (FDRR). To get less people involved, the sponsor must first interact with the deciding official before appealing to higher up management. To read Zachary Brennan’s full article on raps.org, click here.

FDA renaming structure for biosimilars

Recently, FDA released renaming structure for biosimilar products. While biosimilars behave similarly to original product, they are chemically altered. It is because of this that biosimilars must have a different naming system as to not misinterpret the drugs. The guidance states that the new naming structure will involve a “proper name,” which is shared, followed by a four lowercase letter suffix to specify. According to FDA Voice, this new system will allow safer and more accurate monitoring and tracking of products.

To read Michael Mezher’s full article, click here.

US drug shortage is improving, yet continues

For the past two years, drug shortages have been a problem and this year is no exception. In some places, data indicates that the crisis may be coming to a close in the future. In 2011, the US drug shortage was at it’s all-time high at 251 shortages, while in 2014, the number stabilized at 44. The article addresses that although the decrease in shortages show progress for the US, different drugs are being affected and hospitals are constantly in fear of another regression. Valerie Jensen, Director of Drug Shortages Staff, US FDA, believes that the improvements are stemming from better communication between the industry and FDA.

To read Dan Rosenberg’s full article, click here.

Register for the IMDMC workshop on September 10th

On September 10th, the second part of the Indiana Medical Device Manufacturers Council two-day program, REG 102, will be hosted.

This program is designed to provide industry background and knowledge specific to FDA regulations to those who may be new to the industry or regulatory function. Pearl Pathways’ own, John Lockwood, will be speaking on inspections.

When: Thursday, September 10, 2015, 8:00 AM to 4:30 PM EDT

Where: The Montage (8580 Allison Pointe Boulevard, Indianapolis, IN 46250)

To read more details on the topics covered, visit the IMDMC website. To register for the event, click here.

Analysis confirms cause of FDA varied review times

As reported by Alexander Gaffney in RAPS in 2014, the Manhattan Institute of Policy Research (MIPR) claimed that the inconsistencies in review times at FDA were due to inefficiencies by the agency.

Since then, FDA has argued that the variations at the Center for Drug Evaluation and Research (CDER) were caused by accelerated review in specific areas and correlate to proportions of such.

After further data analysis of 250 new molecular entities (NME), it was found that the review time varied based on FDA prioritization of treatments, such as oncology vs. dermatology.

To read Michael Mezher’s full article, click here.

Lessons learned from recent NIH 483s from FDA

The National Institutes of Health (NIH) Clinical Center has suspended operations of its Pharmaceutical Development Section (PDS) facility based on recent FDA 483s that were issued by FDA in May 2015. The facility makes products for certain clinical research studies conducted in the hospital and collaborating facilities. In April, two vials of albumin, used for the administration of the drug interleukin in experimental studies, were found to have fungal contamination after the batch was administered to patients.

Following the fungal contamination complaint, FDA inspected the National Institutes of Health manufacturing site in May of 2015. On June 4th, operations at the Pharmaceutical Development Section (PDS) at the NIH Clinical Center were suspended.

The recent FDA 483 issued to the PDS facility contained 17 detailed observations containing comments such as:

  • “Container closure integrity testing is not performed for any sterile drug products.”
  • “Insects were observed in two (2) of five (5) ISO 7 cleanroom ceiling light bays . . . .”
  • “There is no GMP training program . . . .”
  • “The quality unit is not involved in release of drug products . . . .”

The 483 issued to the NIH brings up several questions – some of which may not be able to be answered due to NIH’s lack of an effective monitoring process.

Who’s in charge of clinical trial manufacturing? How long has NIH been in noncompliance with the basic principles of cGMPs and aseptic processing? How many clinical trial subjects are at risk? What would have happened if this letter was received by a for-profit pharma company?

You can read more about this issue at in-Pharma: http://www.in-pharmatechnologist.com/Regulatory-Safety/House-to-FDA-who-s-in-charge-of-clinical-trial-manufacturing/?utm_source=newsletter_daily&utm_medium=email&utm_campaign=10-Aug-2015&c=frllEubEPtKm0xrxglSmsg%3D%3D&p2



FDA says yes to 3-D drugs

Recently, the US Food and Drug Administration (FDA) has approved the first 3-D printed drug. This drug was created by a private company located in Pennsylvania and has up to 1,000mg of levetiracetam in it. The reason for this drug is to help those who have trouble swallowing pills. Many children, elderly and others have trouble swallowing pills, but thanks to this new pill they now only need one spill of liquid.

Before 3-D printing drugs was created, 3-D printing was used for medical devices and replicating organs. With the news of 3-D printing, many are hoping to create more drugs for those who have troubles swallowing.

To read more on Fiona Barry’s article in in-Pharma, click here.