FDA must clarify flexibilities

The U.S. Food and Drug Administration (FDA) has been called by multiple organizations to clarify its “regulatory flexibility” with orphan drug reviews, according to Michael Mehzer, RAPS. FDA released a draft guidance in August addressing the most common issues faced by drugmakers developing treatments for rare diseases. While many organizations, such as the National Organization for Rare Disorders (NORD), support the guidance, they request more specific information and examples on nonclinical studies, national history studies, endpoint identification, and trial design.

To read Mehzer’s article, click here. Need assistance in managing your orphan drug designation or regulatory filing? Contact us.

CDRH increases foreign inspections as planned

The U.S. Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH) released new data stating that the number of quality systems surveillance inspections for foreign manufacturers increased by 30%, despite the minor overall growth from 2013 to 2014. The increase in foreign inspections provides evidence that the center’s efforts have been working, according to Zachary Brennan, RAPS.

Currently, Chinese manufacturers are requiring more inspections, with Germany and Japan following suit. Although inspections increased abroad, the result of warning levels decreased. The chart below demonstrates the outcomes from domestic inspections compared to foreign inspections.

inspection outcomes

To read Brennan’s article on raps.org, click here.

FDA to exempt genetic screening systems

FDA is contemplating the exemption of specific genetic screening systems that would test parents for conditions that they may pass down to their children; however, FDA states that not all autosomal recessive carrier screening gene mutation detection systems will be included in the exemption.

According to Zachary Brennan, “FDA may exempt a device if the agency determines that a 510(k) application is not necessary to provide reasonable assurance of the safety and effectiveness of a device.” Currently, the screening is only able to determine carriers of the genes, which have caused false positive results and unnecessary psychological distress.

FDA will make its final decision within the next 120 days. For the FDA report, click here. To find out more, visit the article.

FDA aims to hold greater influence in global industry

Recently, Director of the Center for Drug Evaluation and Research at FDA, Janet Woodcock, addressed questions regarding the generic drug user fee act (GDUFA) and whether or not it will provide FDA the means to ensure quality. Woodcock stated that, while it’ll help fund globalization, currently it has limited impact. According to Nick Taylor’s article in In-Pharma, FDA has been attempting to oversee the global pharmaceutical supply chain. FDA is less interested in funding for increased resources, but more for powers to compliment the funds. They aim to bring to attention the problems with importing drugs in the US compared to other countries. Questions have risen regarding whether that would call for different domestic and overseas standards for manufacturers.

For a closer look, click here.

ANDAs approved by FDA

FDA recently announced the approval of the Acceptability of Draft Labeling to Support ANDA Approval guidance. This new guidance states that it is no longer required to submit a final printed label (FPL) to the Office of Generic Drugs in order to approve Abbreviated New Drug Applications (ANDAs).

Previously, the Office of Generic Drugs (OGD) required the submission of FPL because of the accurate layout and design specifications that accompany it in regards to formatting. With electronic submissions becoming more prevalent, the OGD was able to approve labeling review through electronic versions. All drafts must reflect the correct formatting factors, such as colors, font, layout, and information, in order to be considered for approval.

For more information, read Zachary Brennan’s article on RAPS.org. Need help with filing an ANDA regulatory submission? Contact us.

Definition of “interchangeable” key to future of biosimilars

With the approval of Zarxio (filgrastim-sndz), copycat of Amgen’s Neupogen (filgrastim), there has been much speculation on the word interchangeable vs. just a biosimilar, which is Zarxio’s status. According to FDA, a product is interchangeable if it is intended to produce the same result as the original in any patient. Janet Woodcock, CDER director, spoke recently on behalf of the Senate Subcommittee about how the FDA must wait until the guidelines are bulletproof before releasing to the public. Industry is frustrated as they want to obtain the higher interchangeable status but how to prove that remains unknown until FDA publishes final guidance.

Francis Megerlin, the Berkeley Center for Health Technology, stated that the growing use of interchangeable products could cause “a long-lasting competition for chronic treatments,” while also lowering prices by insurers. It is hard to say how much prices will decrease in comparison with the original products and it will have a different effect around the world.

To read Gareth MacDonald’s recent article on BioPharma, click here. To view a past discussion about this debate on businessinsider.com, click here.

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.