Category Archives: Food and Drug Administration (FDA)

Information Explaining the “Right to Try” Legislation and What It Means To Terminally Ill Patients

Q: What is the Right to Try Act?

A: Right To Try is legislation that allows terminally ill patients to access investigational treatments that have passed basic safety testing (Phase I) with the FDA, but are not yet available on pharmacy shelves.

Q: Why was Right To Try developed?

A: Over 1 million Americans die from a terminal illness every year. Many spend years searching for a potential cure, or struggle in vain to get accepted into a clinical trial. Unfortunately, FDA red tape and government regulations restrict access to promising new treatments, and for those who do get access, it’s often too late.

Q: Is Right To Try law in my state?

A: Right To Try has been signed into law in 38 states and counting: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia, Washington, and Wyoming. If your state is not listed, and you want to bring Right to Try to your state, click here to find out how.

For more information about the “right-to-try” legislation please click on the following link to be redirected:

http://righttotry.org/faq/

The Senate in August 2017 passed by unanimous consent a measure designed to make it easier for terminally ill patients to get access to experimental treatments without oversight from the U.S. Food and Drug Administration (FDA)

The “right-to-try” legislation has been championed by the libertarian Goldwater Institute, which has worked to pass similar legislation in 37+ states.

The federal version, now headed to the House, would bar the government from blocking patients from getting access to medications that have undergone only preliminary testing in humans. Patients first would have to try all other available treatments and be ineligible for clinical trials.

The bill would provide drug companies some legal protection if a treatment results in harm.

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To read the article in its entirety please click on the following link to be redirected:

https://www.denverpost.com/2017/08/03/right-to-try-terminally-ill-patients-experimental-drugs-fda/

 

 

 

 

Learn More About Clostridium difficile (C.diff., C.difficile) infection and Recurrent CDI Clinical Trials In Progress

 

 

 

The C Diff Foundation has implemented a global campaign to raise awareness of Clostridium difficile infection (C.difficile) clinical trials, clinical studies, clinical research and observational studies evaluating interventions for C. difficile prevention, treatments, and environmental safety.

In the USA: Nearly half a million Americans suffer from Clostridium difficile (C. diff.) infections in a single year according to a study released in 2015 by the Centers for Disease Control and Prevention (CDC). Approximately 29,000 patients died within 30 days of the initial diagnosis of C. difficile. Of those, about 15,000 deaths were estimated to be directly attributable to C. difficile infections making C. difficile a very important cause of infectious disease death in the United States.

“Clostridium difficile infections are not only the most common cause of healthcare-acquired infections in the United States but also very common in the community in younger patients who previously were thought to be less susceptible to C. difficile. The rate of recurrent C. difficile infections is increasing tremendously and this increase is higher than the rate of primary C. difficile infections,” stated Sahil Khanna, MD, Assistant Professor of Medicine Division of Gastroenterology and Hepatology, Director of the C. difficile Clinic, Fecal Microbiota Transplantation program and C. difficile related Clinical Trials, Mayo Clinic, Rochester, MN.

Dr. Khanna also added, “It is imperative and important for clinical trials to be done to advance the development of new treatments, new medications, and new ways to prevent and treat Clostridium difficile infections.”

Individuals volunteer to participate in clinical trials in hopes of improving their own health, to access treatments that might not be available otherwise, often because they are new and not yet widely available. They help others by contributing to advances in medicine. There can also be potential risks participating in clinical trials and clinical studies. All of the known risks associated with a particular trial and or study will be discussed during the informed consent process. It will be thoroughly explained in the informed consent document that a volunteer will receive from the research staff prior to participating in any study.

To learn more about clinical research (e.g., Clostridium difficile, C.difficile) visit the U.S. Food and Drug Administration http://www.fda.gov or telephone 1-800-835-4709, The National Institutes of Health (NIH) http://www.nih.gov and ClinicalTrials.gov.

“Clinical trials are vital to improving our knowledge about how best to prevent and treat C. difficile infections. Informing patients of clinical trials is important, and in recent years several clinical trials have led to significant improvements in the treatments available for patients with C. difficile infections,” stated Mark Wilcox, MD, FRCPath, Consultant Microbiologist, Head of Microbiology and Academic Lead of Pathology Leeds Teaching Hospitals, Professor of Medical Microbiology University of Leeds Institute of Biomedical and Clinical Sciences, Lead on Clostridium difficile for Public Health England, UK.

About the U.S. Food and Drug Administration (FDA):
The FDA is responsible for protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drug, and vaccines and other biological products and medical devices intended for human use are safe and effective. FDA’s responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions.

About the National Institutes of Health (NIH):
The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency making important discoveries that improve health and save lives.

About ClinicalTrials.gov
ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.

U.S. Food and Drug Administration Advises Serious Side Effects Associated With Fluoroquinolone Antibacterial Medication

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The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.


The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options.  For patients with these conditions, fluoroquinolone should be reserved for those who do not have alternative treatment options. 

The new FDA ruling calling for restricted use of fluoroquinolones affects five prescription antibiotics: ciprofloxacin (Cipro), levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin (Floxin), and gemifloxacin (Factive). All are also available as generics.

https://cdifffoundation.org/2016/05/05/a-study-provides-data-that-between-2010-and-2011-throughout-u-s-at-least-30-percent-of-antibiotics-unnecessarily-prescribed/

 

ANTIBIOTIC STEWARDSHIP PROGRAM UPDATES:

https://cdifffoundation.org/2016/04/29/antibiotic-stewardship-program-and-updates-from-sources-cdc-pew-charitable-trusts-with-idsa-and-shea-guidelines/

 

For Additional Information Regarding This Topic – Please Visit The Following Consumer Article:

http://www.consumerreports.org/drugs/fluoroquinolones-are-too-risky-for-common-infections/

An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together.  These side effects can involve the tendons, muscles, joints, nerves, and central nervous system. 

As a result, we are requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information.  We are continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.

Patients should contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine.   Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations.  Patients should talk with your health care professional if you have any questions or concerns.

Health care professionals should stop systemic fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.  

Fluoroquinolone drugs work by killing or stopping the growth of bacteria that can cause illness.

We previously communicated safety information associated with systemic fluoroquinolone antibacterial drugs in August 2013 and July 2008.  The safety issues described in this Drug Safety Communication were also discussed at an FDA Advisory Committee meeting in November 2015. 

We urge patients and health care professionals to report side effects involving fluoroquinolone antibacterial drugs and other drugs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

For more information, please visit: Fluoroquinolone.

 

Fecal Transplants (FMT) Treating Clostridium difficile Infections; U.S. Food and Drug Administration (FDA) Seeks Comment on What Investigational New Drug (IND) Requirements To Waive

Fecal Transplants to Treat C. difficile: FDA Seeks Comment on What IND Requirements to Waive

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The US Food and Drug Administration (FDA) on Monday February 29, 2016,announced new draft guidance that aims to further assure that patients infected with the bacterium Clostridium difficile and not responding to standard therapies can access poop transplants, also known as fecal microbiota for transplantation (FMT).

FDA considers FMT an investigational new drug (IND), which requires physicians and scientists to file an IND application if they intend to use the treatment for clinical practice or research.

However, FDA has issued guidance stating that FMT may be used to treat 

C. difficile infection not responsive to standard therapies outside of a clinical trial. 

New Guidance

The latest draft guidance offers new notice that FDA intends to exercise enforcement discretion regarding the IND requirements for the use of FMT to treat C. difficile infection.

As far as what FDA wants to discuss on this new draft guidance, the agency says it’s requesting comments on which IND requirements are appropriate to waive.

In particular, FDA is requesting comments on the requirement for institutional review board review of the use of FMT to treat patients with C. difficile infection not responding to standard therapies when the FMT is provided by a stool bank,” FDA says.

Background

The draft guidance comes as over the past few years, FMT, which basically involves the transfer of a healthy donor stool to the bowel of a patient infected with C. difficile, has emerged as an effective means to treat recurrent forms of the bacterial infections, according to a study in the Journal of Law and Biosciences.

Rachel Sachs, an academic fellow at Harvard University’s Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, and an author of that study, explained to Focus that previously FDA said it would regulate FMT like a biologic, but that the decentralized, hospital-based model of FMT envisioned in this new draft guidance more closely resembles the agency’s models for regulating tissue or cord blood products.

Two companies – Rebiotix and Seres Therapeutics – have been granted orphan drug designations for their INDs as FMT treatments for recurrent C. difficile infections, which affect between 85,000 and 110,000 people in the US annually.

And Sachs said she’s under the assumption that once a company gets FDA approval for their FMT product, FDA will revoke its enforcement discretion included in this new guidance.

Guidance Details

FDA said Monday it intends to use this discretion for waiving certain IND requirements, provided that:

  • The licensed health care provider treating the patient obtains consent from the patient or his or her legally authorized representative for the use of FMT products. The consent should include, at a minimum, a statement that the use of FMT products to treat C. difficile is investigational and a discussion of its reasonably foreseeable risks;
  • The FMT product is not obtained from a stool bank; and
  • The stool donor and stool are qualified by screening and testing performed under the direction of the licensed health care provider for the purpose of providing the FMT product for treatment of the patient.

And FDA makes clear that an establishment that collects or prepares FMT products “solely under the direction of licensed health care providers for the purpose of treating their patients (e.g., a hospital laboratory) is not considered to be a stool bank under this guidance.”

Sachs co-authored her article with Carolyn Edelstein, director of policy and global partnerships at OpenBiome, a nonprofit stool bank that sells FMT capsules (recommended dose of 30 capsules plus a safety test capsule costs $535, or stool preparations for delivery by colonoscopy, enema, and EGD/naso-enteric tube are $385 each) after conducting first-in-human evaluations (N=4) and a randomized dose-finding study (N=17).

Edelstein told Focus that the draft “suggests that the FDA is seeking to set up a more tailored regulatory scheme, one that considers stool banking separately from small-scale directed donation. We are in favor of seeing stool banking receive more regulatory oversight. We plan to answer the agency’s request for comments on the elements of a regulatory framework that would lend this oversight to the practice of stool banking without unduly burdening the physicians and healthcare facilities using banked material, and by extension, unduly limiting access to the treatment for their patients.”

FDA also explains that there were “difficulties in interpretation” with previous draft guidance, particularly around the provision that the donor be known either to the patient or to the treating licensed health care provider, noting “the revised approach more accurately reflects our intent to mitigate risk, based on the number of patients exposed to a particular donor or manufacturing practice rather than the risk inherent from any one donor.”

But as new FMTs are likely to hit the market as orphan drugs, the bigger issue at play could be associated with cost. Sachs noted that any FDA-approved treatment, particularly since it’s an orphan product, could be expensive (upwards of thousands of dollars for treatment).

 

Source:

http://www.raps.org/Regulatory-Focus/News/2016/02/29/24428/Fecal-Transplants-to-Treat-C-difficile-FDA-Seeks-Comment-on-What-IND-Requirements-to-Waive/

Merck Nearing FDA Approval For Its Antitoxin (bezlotoxumab) For Prevention Of C. difficile Infection (CDI) Recurrence

Merck  is nearing FDA approval for its Clostridium difficile-fighting antibody, picking up the agency’s priority review designation with the promise of a shortened vetting process.

The FDA accepted Merck’s application for bezlotoxumab and promised to hand down a final decision by July 23, shortening the standard 10-month review to 6 months.

The treatment, licensed from Medarex in 2009, is an antibody designed to block C. difficile toxin B, which damages the gut wall and leads to inflammation that trigger abdominal pain and diarrhea. In Phase III, adding bezlotoxumab to standard of care significantly reduced C. difficile recurrence in high-risk patients after 12 weeks, Merck disclosed in September.

Bezlotoxumab is among the most advanced assets in Merck’s infectious disease pipeline, bolstered by the company’s $9.5 billion buyout of antibiotics specialist Cubist Pharmaceuticals last year. Merck is also at work on therapies for pneumonia, bacterial infection and HIV as it awaits approval for a combination treatment targeting hepatitis C.

 

FULL STATEMENT FROM MERCK:

Merck  known as MSD outside the United States and Canada  January 28, 2016  (today) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence.

The FDA granted Priority Review for bezlotoxumab, with a Prescription Drug User Fee Act (PDUFA) action date of July 23, 2016.

The company also has filed a marketing authorization application for bezlotoxumab with the European Medicines Agency (EMA) that is currently under review.

“Recurrence is a major challenge with C. difficile infection, one of the most common healthcare-associated infections in U.S. hospitals,” said Dr. Roy Baynes, senior vice president of clinical development, Merck Research Laboratories. “Currently, there are no therapies approved for the prevention of C. difficile infection recurrence. As part of Merck’s commitment to the fight against infectious diseases, we look forward to continuing to work with the FDA and EMA to bring forward this novel medicine for appropriate patients.”

The application for bezlotoxumab is based in part on data from the pivota lMODIFY I and MODIFY II clinical trials. Data from these trials were previously presented at the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and International Congress of Chemotherapy and Infection (ICC) 2015 joint meeting.

About bezlotoxumab

Bezlotoxumab is an investigational antitoxin given in conjunction with standard of care antibiotics that are used in the treatment of C. difficile infection. It is not an antibiotic. Bezlotoxumab is designed to neutralize C. difficile toxin B, a toxin that can damage the gut wall and cause inflammation, leading to C. difficile-associated diarrhea.

About Merck

Today’s Merck is a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visitwww.merck.com and connect with us on TwitterFacebookYouTube and LinkedIn.

Forward-Looking Statement of Merck & Co. Inc., Kenilworth, NJ, USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2014 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

To read this article in its entirety please click on the link below:

http://www.fiercebiotech.com/press-releases/merck-announces-fda-acceptance-biologics-license-application-bezlotoxumab-i

 

FDA Issues Warning Letters To Three U.S. Dairy Farms And Two Food Importers

 

FOOD SAFETY NOTICE:

Three U.S. dairy farms and two food importers were on the receiving end of warning letters recently from the Food and Drug Administration.

The warning letters to the dairy farms cited animal drug violations involving antibiotics. The warnings to food companies in French Polynesia and Sri Lanka that import fish and juice to the U.S. concerned violations of food safety regulations related to hazard analysis and control programs.

William W. Van Norstrand, owner of the Vansridge Dairy in Scipio Center, N.Y., was warned about the sale of an animal for food that had illegal drug residue. FDA referenced the August 2015 sale and slaughter of a dairy cow that showed penicillin residue in kidney tissue of 0.058 parts per million (ppm) in analysis by the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS). The FDA’s established tolerance lever is 0.05 ppm in uncooked, edible tissues of cattle.

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The FDA warning letter said: “The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated …”

 

 

 

Another FDA warning letter went to the five managing partners of the Legacy Ranch #2 in Tulare, Calif., also over animal drug issues.

Dairy cows at the ranch received injections of sterile penicillin G procaine that did not follow the ranch veterinarian’s directions for use with regard to dosages per injection site and failure to meet the minimum withdrawal period before slaughter, according to the warning letter. The “extricable use” of the antibiotic was not under the supervision of a licensed veterinarian, the letter from the FDA’s San Francisco district office said.

 

The Hawk Dairy Farm in Minerva, Ohio, was the third dairy farm to receive a warning letter, also regarding penicillin residue.

In March 2015 the farm sold a dairy cow for slaughter as food. The FSIS analysis of kidney tissue samples collected from the animal showed the presence of penicillin at 0.363 ppm, which is in excess of the federal 0.05 ppm tolerance level.

In addition, FDA said the Hawk Dairy holds “animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.”

In warning letters to S.A.R.L. Pacific Tuna in French Polynesia, and to Target Agriculture in Sri Lanka, the FDA told the companies the United States will likely refuse admission to their products unless they quickly adopt the agency’s advice about Hazard Analysis and Critical Control Point (HACCP) regulations.

In the warning letters, FDA gives Pacific Tuna lengthy and specific instructions on how to comply with seafood HACCP regulations. The agency gives similar details instruction to Target Agriculture on juice HACCPs.

 

Resource:

http://www.foodsafetynews.com/2016/01/fda-issues-warnings-to-3-dairy-farms-2-food-importers/#.Vp5A71Ji9Qt