My Horse Daily Says to Just Say No

Just Say No to (Unapproved) Drugs for Your Horse

February 28, 2013

The recent human meningitis outbreak, caused by the injection of contaminated compounded steroid products prepared by the New England Compounding Center, has put compounding pharmacies into the daily headlines.
But it isn’t just human drugs consumers should be concerned about. Compounding pharmacies prepare drugs for horses, as well. In 2009, a vitamin and mineral supplement prepared by Franck’s Compounding Lab in Ocala, FL included an excessive amount of one ingredient (selenium) that resulted in the death of 21 polo ponies.
In other cases of questionable drug safety, illegal products that claim to be “the same as” name brand drugs are marketed to consumers, sometimes with devastating results. In 2006, a reported six horses died as a result of using an illegal clenbuterol product.
Unfortunately, in these cases, the results of using non U.S. Food and Drug Administration (FDA) approved drugs were tragic. In other instances, while the unapproved and unproven products may not be particularly harmful, they may not contain the labeled amount of active ingredient, or do what they claim to do.
Studies presented at the American Association of Equine Practitioners (AAEP) Convention in prior years have shown a wide range in the pharmaceutical equivalence of compounded drugs when compared to brand name drugs. In 2003, Scott Stanley, PhD, presented findings from a study evaluating compounded versions of the FDA-approved drugs ketoprofen, amikacin and boldenone. In the case of ketoprofen, one compounded preparation contained just one-half of the expected concentration.
With amikacin, some compounded preparations had less drug, between 59 percent and 76 percent of what was stated on the label. Other compounded versions of the drug had more than the stated concentration: 112 percent and 140 percent.
Dr. Stanley conducted similar research on compounded versions of omeprazole, presenting his findings at the 2011 AAEP Convention. The compounded omeprazole products ranged from more than 100 percent to approximately 63 percent of the concentration claimed on the label.
After 60 days, the compounded versions lost potency, with the amount of active ingredient varying from 82 percent to as little as 17 percent.
At the 2012 AAEP Convention, Dr. Stanley presented results from a similar study, this one comparing compounded formulations of clenbuterol with the FDA-approved version. His findings showed the compounded formulations varied from containing as little as 32 percent of the labeled concentration up to more than 316 percent of the labeled concentration.
“What these studies have shown is that compounded versions of equine drugs, in many cases, do not contain the proper concentration of the active ingredient,” says April Knudson, DVM, equine specialist, Merial Large Animal Services. “If they don’t have enough of the active ingredient, it’s a natural conclusion they won’t work as well, if at all. If they have too much of the ingredient, it’s possible there will be a detrimental effect on the horse’s health, depending on the ingredient,” she says.
Additionally, merely containing the same active ingredient as a brand name drug does not guarantee efficacy or safety. The proper formulation is often an essential part of making a safe and efficacious product.
How can horse owners be sure they are getting a product that is safe and will do what it claims on the label? By making sure that product is FDA approved.
Drugs that are approved by the FDA are:

• Tested in the target animal in field trials and in the laboratory.
• Manufactured according to Good Manufacturing Practices, which ensures consistency.
• Manufactured in inspected facilities that meet FDA guidelines.
• Labeled with information that can be scientifically substantiated.
• Advertised in such a way as to not be false or misleading.
• Monitored following approval for adverse events.

Because many of these unapproved drugs are made to look like the approved drugs, horse owners should be wary and do their homework.

Whether a product has been FDA-approved can be determined by checking the searchable database at AnimalDrugs@FDA (http://www.accessdata.fda.gov/scripts/animaldrugsatfda/. Most generic and brand name drugs also feature a number on the label indicating FDA approval. In the case of brand name drugs, look for the six-digit New Animal Drug Application (NADA) and for generics, the Abbreviated New Animal Drug Application (ANADA) number.

“Horse owners have a lot of financial and emotional investment in their horses,” says Dr. Knudson. “Taking some time to research the products available and make educated decisions should help them keep their horses healthy in the long run.”

For more information about the types of products available and the importance of FDA approval, go to equinedrugfacts.com.

Source found here

FDA MATTERS: The State of the FDA—February 2013 Funding Agency Mission “At Risk”, Says Alliance President

 FDA’s mission is “at risk” because of inadequate funding. So says Alliance for a Stronger FDA President Diane Dorman, testifying before the FDA Science Board. Her remarks come 5 years after the Science Board made a similar declaration, concluding that decades of underfunding had left FDA without the resources to fulfill its mandate and make science-based decisions.

Congress responded with more monies for the agency, but since then the FDA’s workload has increased even faster. The current threat to FDA comes from two sources: four major new laws to implement since 2009; and changes in the environment in which FDA operates, notably acceleration of globalization and increasing scientific complexity.

Ms. Dorman’s remarks are reprinted below. If you care about FDA, FDA Matters urges you to read her testimony, go to the Alliance’s site (www.StrengthenFDA.org) and join.

Testimony of Diane E. Dorman

President, Alliance for a Stronger FDA

Before the

Science Board of the U.S. Food and Drug Administration

February 27, 2013

Good afternoon and thank you for the opportunity to address the FDA Science Board.

My name is Diane Dorman and I am President of the Alliance for a Stronger FDA, as well as Vice President for Policy at the National Organization for Rare Disorders. The Alliance is a 200-member coalition of all FDA’s stakeholders—consumers, patients, health professionals, trade groups and industry. Our sole purpose is to advocate for increased appropriated resources for the FDA.

When we started in 2006, FDA appropriations stood at slightly less than $1.5 billion for an agency tasked with overseeing 100% of drugs, vaccines, medical devices, and personal care products and 80% of our nation’s food supply. Altogether, the products and industries regulated by FDA account for nearly 25% of all consumer spending in the United States.

In short, FDA was the victim of decades of underfunding. It was quite small, despite its vital, complex world-wide responsibilities. Presidents weren’t asking for nearly enough money for FDA and Members of Congress were responding by giving the bare appropriations that had been asked for.

The Alliance’s goal was to change this situation by galvanizing the FDA’s broad stakeholder community to focus attention on the consequences of underfunding. We never doubted the accuracy of our analysis or the importance of our cause.

Nonetheless, it was immensely helpful when–18 months after our founding–the FDA Science Board released its own report in November 2007. As the media described it—the FDA’s own Science Board evaluated the agency’s capacities and responsibilities and declared that the agency’s mission was “at risk.” The word “crisis” was often used and was an appropriate description of the situation.

Subsequently—and with the Alliance’s broad stakeholder advocacy—the prospects for FDA improved. Policymakers acknowledged the underfunding and acted aggressively to reverse it.

Continue reading testimony here 

Pharmacy gave out poison to get rich, NECC meningitis patient says Hundreds of cases tied to Framingham compounding pharmacy Published 5:11 AM EST Feb 28, 2013

BOSTON —The last steroid injection Darrel Clark received for his back pain happened days before doctors diagnosed him with fungal meningitis.

Read more: http://www.wcvb.com/news/local/metro-west/Pharmacy-gave-out-poison-to-get-rich-NECC-meningitis-patient-says/-/11983044/19118272/-/37pahfz/-/index.html#ixzz2MGA6dLLH

CVMA 129th Annual Meeting & Convention--March 26-27, 2013

3/26/2013 - 3/27/2013


Come and join us at Connecticut Convention Center, Hartford, CT for their 129th Annual Meeting & Convention.
Click here for more information! 

Oregon Veterinary Conference

March 8 - 10, 2013

CH2M Hill Alumni Center & LaSells Stewart Center
Oregon State University, Corvallis, Oregon

Online Registration

CVM Students

• Student Registration

Veterinarians and Healthcare Team

OVMA members receive a 30% discount on OVC registration fees! Not a member? Apply online. And check out the other benefits of OVMA membership.

• Full Conference Registration
• Friday Only
• Saturday Only
• Sunday Only

There are still spots available in both the AM and PM Hematology Labs on Saturday. These are first-come, first-served.

Proceedings

Please print the proceedings for the sessions you plan to attend and bring them with you to the conference, or load them to your laptop, smartphone or tablet.

Access the proceedings here.
Requires the username and password from your conference confirmation card or e-mail.

Note: If you are already logged into the site as an OVMA member, you will need to logout first and then login again using the 2013 OVC registrant name and password.

Brochure & Registration Forms

• 2013 Oregon Veterinary Conference Brochure

Prefer to register by fax, e-mail or US mail? Download the registration forms below and remit to the OVMA with payment.

• 2013 Oregon Veterinary Conference Registration Form: DVMs & CVM Students
• 2013 Oregon Veterinary Conference Registration Form: Healthcare Team

CE Form

You will receive your CE form at the conference. Contact us if you need a CE form from a previous year.

 

Speakers & Topics

Companion Animal

Nephrology & Urology ~ Dr. David Polzin

Dermatology ~ Dr. Ken Kwochka Sponsored by Bayer Health Care Animal Health (formerly Teva Animal Health)

Complementary Therapies ~ Dr. Gregory Todd

Surgery ~ Dr. Jennifer Warnock

Equine

Wound Management ~ Dr. Gary Baxter

Evaluation of Acute Phase Proteins to Predict Clinical Outcome for Inflammatory Diseases ~ Dr. Keith Poulsen

Update on Equine OCD ~ Dr. Stacy Semevolos

Neonatal Care ~ Dr. Nathan Slovis

Non-Traditional Routes of Administration for Tiludronate in Horses: Are They Safe? ~ Dr. Katja Zellmer

Food Animal

Update on Residue Management, Vaccination Recommendations for Dairy Herds~ Mark Kirkpatrick, DVM, MS Sponsored by Zoetis (formely Pfizer)

Status Update: Animal Health Division ~ Brad LeaMaster, PhD, DVM

Why Vaccine Associated Reactions Occur, Emerging Cattle Pathogens ~ Rich Linhart, MS, DVM, DACVT Sponsored by Zoetis (formely Pfizer)

Pinkeye & Pinkeye Prevention, Current Issues in “Organic” Production Animals and Selenium Issues ~ John Maas, DVM, MS, DACVIM Sponsored by Merial

Long-Acting Parasite Control in the Bovine ~ Tony Moravec, DVM Sponsored by Merial

Ruminant Nutrition 701,  Promoting & Defending Conventional Agriculture in a Facebook Culture ~ Gary Sides, PhD Sponsored by Zoetis (formely Pfizer)

Animal Welfare

Marine Mammals ~ Dr. Bruce Mate, Hatfield Marine Science Center Sponsored by the Oregon Animal Health Foundation

Technicians & Assistants

Pathology ~ Janell Bishop-Stewart

Exotics ~ Dr. Mark Burgess

Keeping the Veterinary Team Safe (Zoonoses) ~ Dr. Emilio DeBess

Coagulopathies & Toxicosis ~ Dr. Heidi Houchen

Cardiac Monitoring ~ Dr. Holly MacLea

Behavior ~ Dr. Christopher Pachel

Hematology Lecture & Lab ~ Dr. Sandy Willis Sponsored by Phoenix Central Lab

Anesthesia & Pain Management ~ Dr. Heidi Shafford

Practice Management & Team Development

Affordable Care Act ~ Tim Berry

Preventive Pet Care ~ Dr. Nan Boss

Controlled Substances ~ Claire Brennan (DEA)

Communications ~ Louise Dunn Sponsored by Care Credit

Licensing Board Update ~ Lori Makinen & Dr. Mark McConnell

APHIS Accreditation Renewal

Training Modules Needed for Accreditation Renewal (SA/LA) ~ Dr. Brianna Wilson Schur

Source found here

Maryland Senate Hearing Set for 3/13/13 1:00 on Proposed Legislation Relating to Compounding

Requiring a sterile compounding facility to hold a sterile compounding permit issued by the State Board of Pharmacy before the sterile compounding facility may perform sterile compounding in the State; providing that a sterile compounding permit is required in addition to and does not replace other permits or licenses; requiring a sterile compounding facility that performs sterile compounding outside the State to hold a sterile compounding permit issued by the Board under specified circumstances; etc.

For more information see here

After failures,Massachusetts DPH seeks 30 new staffers to boost inspection ability

After failures, DPH seeks 30 new staffers to boost inspection ability

California Bill Would Implement Stricter Requirements for Pharmacies Compounding Sterile Drugs

February 27, 2013 5:05 p.m.

Pharmacies compounding sterile drug products for dispensing to patients in California would be required to obtain a license to engage in that practice under a bill (SB 294) introduced to the state’s senate on February 19, 2013. Under the bill, both resident and nonresident pharmacies that compound sterile products for dispensing or shipment into the state must apply to the California State Board of Pharmacy for licensure. An on-site inspection by the Board would be required prior to licensure. Nonresident pharmacies would be responsible for payment of travel expenses of the Board in connection with an inspection. In addition, a list of all sterile drug products compounded by the pharmacy must be provided to the Board, as well as notification of any disciplinary action taken by another state or suspension of any accreditation held by the pharmacy.

Source is NABP

FDA has plenty of ways to cut spending, with or without sequester - Related Stories - FDLI SmartBrief

FDA has plenty of ways to cut spending, with or without sequester - Related Stories - FDLI SmartBrief

AVMA Now: Video Update from the Governmental Relations Division on Fairness to Pet Owners Act, Drug Compounding, and Controlled Substance Laws

AVMA NOW: Update from the Governmental Relations Division

ANIMAL HEALTH SMARTBRIEF | FEB 19, 2013

The Fairness to Pet Owners Act, drug compounding and controlled substance laws are among the many issues facing veterinarians today. A new Congress is in place, and with it comes a certain amount of uncertainty about what’s going to happen with these important issues. In this episode of AVMA NOW, Dr. Mark Lutschaunig, director of AVMA’s Governmental Relations Division, discusses the status of these issues and what the AVMA is doing to protect and promote the veterinary profession on Capitol Hill.Watch the episode.

University of Iowa IACUC Guidelines: Use of Drugs and Chemicals in Laboratory Animals With Useful Flow Chart Submitted by kzobeck on Fri, 02/22/2013 - 14:53

These guidelines describe the requirements regarding the use of drugs and other chemicals administered to laboratory animals at the University of Iowa. The use of drugs falls into one of two usage categories: therapeutic purposes or experimental use. These guidelines apply to both categories of administration. Deviation from these guidelines must be described and justified in an IACUC-approved Animal Protocol. 

The use of non-pharmaceutical grade compounds in animals may be necessary and appropriate, but must be scientifically justified in an IACUC-approved Animal Protocol.

Definitions

• Pharmaceutical grade compound: Drug, biologic, or reagent which is approved by the FDA or for which a chemical purity standard has been established by USP/NF or BP.
• Non-pharmaceutical grade compound:  Any substance which does not meet the above definition of pharmaceutical grade, including:
  • Analytical grade bulk chemical: ~99% purity chemical, Certificate of Analysis typically available
  • Pharmaceutical grade drug compounded with non-pharmaceutical grade vehicle or other substance
• FDA – Food and Drug Administration
• USP/NF – United States Pharmacopeia/National Formulary
• BP – British Pharmacopeia

Drugs Administered for Therapeutic Purposes

• Current standards for the veterinary therapeutic care of research animals state that pharmaceutical grade medications should be used for routine medical treatment
• Examples of therapeutic purposes include:
  • Sedation and anesthesia for surgery or other procedures
  • Relief or treatment of disease or injury  
  • Pain control (analgesia)
  • Euthanasia
• Drugs used for veterinary care, either as part of an IACUC-approved Animal Protocol or an OAR veterinarian-approved treatment plan, should be obtained from a veterinary supply or from a pharmaceutical supplier licensed by the FDA, if available from such sources

Popular pet ointment nixed

Zoetis, the animal health unit of pharmaceutical giant Pfizer, plans to stop making Panolog, a popular ear-and-skin medication for pets.

“We have made the decision to discontinue production of our Panolog ointment and cream products,” Zoetis spokesman Deron Johnson told Examiner.com in a two-sentence statement Feb. 25. “This decision is based on a regular review of our product portfolio and consideration of future API (active pharmaceutical ingredient) supplies; it is not related to the quality or integrity of the finished product currently available on the market.”

More details about the prescription drug’s demise were not immediately available from Zoetis.

Panolog cream and ointment are used to treat skin infections in cats and dogs. The ointment also is used to treat ear infections in pet.

Continue reading here

FDA Doesn't Plan Furloughs; Eyes Training, Contract Cuts If Sequestration Kicks In

FDA does not currently anticipate having to furlough employees if the cuts mandated by sequestration go into effect Friday (March 1), but will likely reduce travel and training, and curtail contracts and outside collaborations.

1377 words

Source HealthPolicyNewstand

Sterile compounding lessons to be learned

FEB 27, 2013

Source found at Drug Topics

By: Michelle Sprehe, Digital and Interactive Content Producer

The importance of cleanliness and being proactive were the two most important lessons learned following the New England Compounding Center’s practices that led to the nationwide fungal meningitis outbreak, said sterile compounding expert Eric Kastango, MBA, RPh, FASHP.

"This is probably the most catastrophic event that has happened in my lifetime, as it relates to compounding," Kastango said during a web seminar Feb. 20 sponsored by Pharmacy OneSource.

In October 2012, the FDA issued a 483 form to NECC, detailing the filthy conditions of its main clean rooms, gown rooms, prep rooms, and adjacent rooms, as well as observations of vials of methylprednisolone acetate (preservative free) 80 mg/mL from one of the lots known to be contaminated with fungus.

"It's mind-blowing," Kastango said of FDA's findings. "If you have a person in a clean room, you're going to have micro-organisms."

It was noted that the air-conditioning was turned off at 8 pm to 5:30 am in the clean room, according to personnel who were interviewed during the FDA inspections.

Sequester, Hitting HHS Anti-Fraud Efforts, Could Lead To Smaller Returns

02-27-2013

If the budget sequester kicks in March 1, cuts slated for CMS' anti-fraud, waste and abuse activities will have a multiplying effect as funding reductions in those areas could also reduce the amount of money program integrity activities are able to return to the Medicare trust fund, CMS Center for Program Integrity Director Peter Budetti told lawmakers Wednesday (Feb. 27).

Source HealthPolicyNewstand

Drug Companies Start Buying Off Doctors In Med School Carl Lowe | Feb 28, 201

Medical schools say they are trying to keep drug companies away from medical students. But a survey of medical students and residents shows that pharmaceutical sales reps are still sending medical students gifts, buying them meals and generally trying to bribe them with industry-sponsored educational materials.

“In medical school and residency, as trainees are learning the fundamentals of their profession, there is a need to ensure the education they receive is as unbiased as possible,” warns researcher Dr. Aaron Kesselheim of Brigham and Women’s Hospital in Boston. “However, it is well known that promotional information and gifts from pharmaceutical companies can encourage non-evidence-based prescribing. Though many institutions have tried to insulate trainees from these effects, trainees’ exposure to industry promotion is still quite high.”

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The survey shows that one-third of first-year students and more than half of fourth-year students and residents report receiving industry-sponsored gifts.

source found here

New meningitis cases from tainted medicine still occurring in Michigan; outbreak from Massachusetts company started in October - theoaklandpress.com

New meningitis cases from tainted medicine still occurring in Michigan; outbreak from Massachusetts company started in October - theoaklandpress.com

Did the state drop the ball in protecting residents from the meningitis outbreak?

Did the state drop the ball in protecting residents from the meningitis outbreak?

Dr. Omidi's Blog: WEDNESDAY, FEBRUARY 27, 2013 Controversy in Culpability Surrounding Meningitis Outbreak

Because the fungal meningitis outbreak was so catastrophic in terms of lives lost and pain needlessly suffered, it was only a matter of time before survivors began to seek remuneration from the parties responsible. Not only are the owners of the compounding pharmacy being sued, many of the physicians who administered the tainted shots are also facing litigation.

While it cannot be denied that the blame for the fungal meningitis disaster lays at the feet of a compounding pharmacy that flouted not only governmental regulations, but also basic pharmaceutical practices of health, safety and due diligence, many patients are nonetheless beginning to wonder if the clinics that administered the tainted shots shouldn’t bear some responsibility as well.

The entire matter is extremely delicate. While it is true that the New England Compounding Center was woefully inept at maintaining an environment suitable for the production of an extremely delicate and difficult to manufacture drug, the Massachusetts regulatory boards did little, if anything to oversee or police their practices. The NECC was inspected several times by the FDA as well as state board officials, who issued warnings and concerns that were completely ignored, and yet the regulatory bodies did nothing to follow up on those warnings, leaving thousands of patients in jeopardy.

One of the main reasons compounding pharmacies distribute so many vials of epidural steroid is because many physicians believe in the studies that report of the dangers of using injectable drugs that contain preservatives. While there are many conflicting studies regarding the potential hazards of preservatives in injectable applications, the crux of the objection to the commonly used pharmaceutical preservatives is that they may trigger outbreaks of arachnoiditis, an incurable inflammation of the arachnoid membrane which surrounds the spinal column. This condition is painful, chronic, has debilitating side effects, and requires more or less constant pain management therapy and treatment. Injectable steroids that do not contain preservatives can only be obtained through compounding pharmacies, not FDA regulated drug companies

.

Blog found here

Hospira issues 3 recalls as it faces crucial FDA inspection

February 27, 2013 | By Eric Palmer

Sterile injectables maker Hospira ($HSP) is having to recall lots of 5 different products even as FDA inspectors are in one of its plants conducting what the company hopes will be a final inspection that will return the drugmaker to the agency's good graces.
Over the last several days, Hospira recalled three lots of propofol injectable emulsion after reports came to light that some vials had visible particles embedded in the glass. These were found in some retained samples. It is recalling one lot of preservative-free morphine sulfate injection after a customer found either a loose crimp or no crimp on the flip-top vial, which raises the possibility of contamination. It also recalled three lots of diazepam injection, furosemide injection and Quelicin (succinylcholine chloride) injection for the same problem with loose crimping in flip tops.
The company said all of the recalls are voluntary and there have been no reports of patients being affected by any of the recalled products, although in each case there is a chance for serious effects.


Read more: Hospira issues 3 recalls as it faces crucial FDA inspection - FiercePharma http://www.fiercepharma.com/story/hospira-issues-3-recalls-it-faces-crucial-fda-inspection/2013-02-27#ixzz2MAnwvSbt
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FDA HAS RAMPED UP INSPECTIONS OF APIs--From FiercePharma Manufacturing: FDA warning to Abbey questions quality of API for sterile drugs Warning Letter lists repeat violation on water quality February 27, 2013 | By Eric Palmer Read more: FDA warning to Abbey questions quality of API for sterile drugs

The FDA says an active pharmaceutical ingredient maker in Philadelphia had yet to qualify that its purified water was in fact pure enough to make APIs two years after the agency noted a deficiency.
Abbey Color was told in a new warning letter posted to the FDA website this week that the agency is dissatisfied with the steps the company has taken to demonstrate that its water is suitable for use in manufacturing fluorescein USP, an API used in sterile drug products.
The inspection was conducted nearly a year ago, but the agency notes the company had promised in 2010 that it would make sure it had a reliable source of quality water. The most recent inspection found Abbey still passes spec endotoxin and total organic carbon test results. But inspectors found the operational parameters and effectiveness of an endotoxin removal unit had not been qualified and that Abbey was not monitoring the microbial and chemical attributes of the feed water.

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Sign up for our FREE newsletter for more news like this sent to your inbox!The FDA also came down on the company for not getting to the root cause of its water-supply issues. The manufacturer was further criticized for not setting up an adequate program to monitor API stability that would determine how the API should be stored.
The FDA has been ramping up inspections of APIs, and drugmakers using additional user fees that kicked in this year from generic manufacturers. But that work is being put to risk by looming across-the-board budget cuts from the current sequestration fight in Congress. A recent Congressional Budget Office (OMB) ruling said that user fees have to be cut as well. Regulatory Focus recently figured the cuts would mean a loss of about $200 million from the FDA's base budget and an estimated $112 million (annualized) in lost user fees.

- here's the warning letter

Read more: FDA warning to Abbey questions quality of API for sterile drugs - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-warning-abbey-questions-quality-api-sterile-drugs/2013-02-27#ixzz2MAm4Tpmh
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FDA's Drug Center Creating New Office Of Pharmaceutical Quality, Hamburg Says Wednesday, February 27, 2013 from Pharmaceutical Law & Industry Report ®

By Bronwyn Mixter 
The Food and Drug Administration's Center for Drug Evaluation and Research is working on creating a new office of pharmaceutical quality, FDA Commissioner Margaret A. Hamburg said Feb. 22.
Speaking at the Generic Pharmaceutical Association's (GPhA) annual conference, Hamburg said the new office would not impose any new quality requirements but rather enforce existing quality standards.
“We must be strategic and have systems in place for continual quality surveillance,” Hamburg said. “Quality is one of our highest priorities” in 2013, she added.
In 2012, CDER Director Janet Woodcock said CDER was exploring the idea of creating a new Office of Pharmaceutical Quality (OPQ) to oversee quality throughout the lifecycle of a drug (10 PLIR 1196, 9/14/12).

Generic User Fees

Hamburg also said the Generic Drug User Fee Amendments of 2012 (GDUFA) is moving forward, and “it is going to make an enormous difference.”
The generic drug user fees give FDA the funding it needs to reduce the backlog of generic drug applications, Hamburg said.
Hamburg said FDA has collected $125 million in GDUFA fees for 2013 so far. However, she noted, the budget situation and sequestration have “significant implications” for using generic user fees and budget dollars. Budget cuts under the Budget Control Act of 2011--known as sequestration--are scheduled to be implemented at the beginning of March, while legislation funding the federal government expires at the end of March. In September 2012, a report from the White House Office of Management and Budget classified all budgetary resources available to FDA, including user fees, as subject to sequestration (10 PLIR 1332, 10/12/12).

Biosimilars

FDA is moving forward with creating a biosimilars pathway, Hamburg said. A pathway to approve biosimilars was created in a 2010 law, but FDA is still implementing it.
In 2012, FDA issued three draft guidances for industry on biosimilars, and the agency “is moving forward to finalize” these guidances, Hamburg said (10 PLIR 173, 2/10/12).
“So far FDA has yet to receive an application for a biosimilar product,” Hamburg said. “We are ready” and “eager to engage in that next stage of the process.”
Hamburg said FDA has met with several manufacturers about developing biosimilar products.
Additionally, Hamburg said FDA is seeking public comments on its strategic plan to prevent drug shortages. FDA published a notice requesting comments in the Feb. 12 Federal Register (78 Fed. Reg. 9,928) (11 PLIR 206, 2/15/13). The Food and Drug Administration Safety and Innovation Act (FDASIA) requires the development and implementation of a strategic plan for enhancing FDA's response to preventing and mitigating drug shortages, according to the notice.

---

The Federal Register notice requesting comments on FDA's drug shortage plan is at http://www.gpo.gov/fdsys/pkg/FR-2013-02-12/pdf/2013-03198.pdf.

Source found here

Ed Silverman's Pharmalot blog-What’s Not To Like? Facebook And The FDA

• Pharma Blog » 2013 » February » 27

Last month, the FDA tagged a dietary supplement maker for a laundry list of infractions, but one item tucked away in a December 11 warning letter stands out. The agency complained to Amarc Enterprises that one of its products was ‘liked’ last year on its Facebook page. This was cited as one example of numerous testimonials that could be construed as claims that cause the Poly MVA supplement to be considered a drug. - See more at: http://www.pharmalot.com/2013/02/whats-not-to-like-facebook-and-the-fda/#sthash.ewA1JpWz.dpuf

FDA wants to regulate drug firms on the Internet, is targeting Facebook likes - Health - AEI

FDA wants to regulate drug firms on the Internet, is targeting Facebook likes - Health - AEI

FDA Guidance Clarifies Process for Disclosing Conflicts of Interest in Trials

FDA Guidance Clarifies Process for Disclosing Conflicts of Interest in Trials

FDA does not anticipate furloughs if automatic budget cuts hit POSTED: Wednesday, February 27, 2013, 6:52 AM David Sell

If automatic federal budget cuts kick in Friday, patients, pharmaceutical companies — and the authorities paid to protect the first group and watch over the second — could be effected soon and over time.

Evaluations of drugs and medical devices might take longer as the Food and Drug Administration curtails operations. Patients might not get some medicine. Philadelphia Airport handles shipments of products and executives in the globalized drug business, so customs inspections, screening of passengers and air traffic control might delay delivery of both. Philadelphia has also been a hub of investigation and prosecution of health-care fraud, and the Justice Department expects temporary furloughs for employees.

The White House said Sunday night that the legally mandated cuts (yes, “sequestration”) would mean cuts of 13 percent for defense programs and 9 percent for non-defense programs through the end of the fiscal year on Sept. 30. Last fall, the Office of Management and Budget estimated that an 8.2 percent cut for FDA would amount to $318 million.

“A sequestration of the magnitude contemplated, and this late in the budget year, will have public health consequences for an agency that is already making every dollar count,” FDA spokeswoman Erica Jefferson said Tuesday.

As of Tuesday, Jefferson said, the FDA did not anticipate furloughing employees, but will meet its tighter budget through cost cuts in travel and training, contracts and collaborations. The FDA has a regional office in Philadelphia, and 13 foreign offices in Asia, Europe, Latin America, Africa and the Middle East, but overseas inspections could be impacted.

User fees paid by branded and generic drug companies were meant to help fund the FDA’s evaluation process, but budget cuts won’t help that effort.

There were goals for such approval decisions previously, but no new timetable has been established.

Continue reading here

Advocate says FDA mission 'at risk' from lack of funds By Elise Viebeck - 02/27/13 03:00 PM ET fda budget

The head of a stakeholder group told the Food and Drug Administration (FDA) Wednesday that funding has not kept pace with the agency's ever-expanding portfolio. 

Diane Dorman, president of the Alliance for a Stronger FDA, told the agency's Science Board that the current $2.5 billion budget is "dramatically less" than the FDA requires. 

"This amount might have met the FDA's funding needs in late 2007 ... but not now," Dorman said. 

Read more: http://thehill.com/blogs/healthwatch/medical-devices-and-prescription-drug-policy-/285309-advocate-says-fda-mission-at-risk-from-lack-of-funds#ixzz2MAf3aifI 
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