Showing posts with label fda. Show all posts
Showing posts with label fda. Show all posts
Thursday, October 15, 2015
QLasers False Claims Verified
A permanent injunction has been granted to the Food and Drug Administration (FDA) against Robert “Larry” Lytle, doing business as QLasers PMA and 2035 PMA based on evidence of false and misleading claims regarding the health benefits of these lasers, which in some cases, reportedly cause health problems.
Thursday, September 3, 2015
FDA Cannot Prohibit the Promotion of Truthful, Off-Label Uses
Last week, a federal judge ruled that the Food and Drug Administration (FDA) cannot prohibit a pharmaceutical company from marketing its drugs for off-label uses if its claims are truthful and not misleading. This ruling, while not precedential, alters the traditional compliance regarding the legality of off-label marketing.
In 2012, the FDA approved Amarin’s drug, Vascepa®, for patients with very high triglyceride levels, a condition known to increase the risk of pancreatitis and cardiovascular disease. However, the FDA rejected a second use of the drug that would have allowed Amarin to market Vascepa to patients with persistently high triglycerides who also take statins (i.e., drugs used to lower cholesterol). Although it was undisputed that Vascepa was safe and effective in reducing such triglyceride levels, the FDA told Amarin it needed to submit additional data regarding whether lowering triglyceride levels for patients on statins actually translates to a reduced cardiovascular risk. Absent formal approval, the FDA contended that distributing information about the alternate use would constitute misbranding under the Federal Food, Drug, and Cosmetic Act (FDCA).
Amarin subsequently filed a lawsuit seeking declaratory and injunctive relief that would prevent the FDA from prosecuting it for truthful, non-misleading speech concerning Vascepa. Amarin argued that the FDA’s efforts to stop it from sharing “off-label” information would violate its free speech protections. In a 71-page opinion, Judge Engelmayer agreed with Amarin and ruled that, consistent with the First Amendment, Amarin “may engage in truthful and non-misleading speech promoting the off-label use of Vascepa.”
The FDA has 60 days to appeal Judge Engelmayer’s ruling. If the decision stands, it could continue to pave the way for pharmaceutical companies and medical device manufacturers to engage in the off-label marketing of drugs that is truthful and not misleading. While Amarin and Caronia signal a potential change in the way the government will have to approach off-label marketing cases, it is important to note that these decisions both come out of the Second Circuit, and it still is uncertain how other circuits will rule when presented with similar facts.
Thursday, June 18, 2015
Merck Fraudulently Promoted Pink Eye Medicine Costs Them $5.9 Million
According to Reuters and the Wall Street Journal Merck & Co Inc has agreed to pay $5.9 million to resolve claims that a former unit fraudulently promoted a drug used to treat pink eye for unapproved purposes, U.S. authorities announced on Wednesday.
Manhattan U.S. Attorney Preet Bharara said Inspire Pharmaceuticals, which Merck acquired in 2011 and later sold, promoted its drug AzaSite to healthcare providers for uses the Food and Drug Administration had not approved as safe and effective.
While the FDA had approved AzaSite for treating bacterial conjunctivitis, or pink eye, Inspire sought more revenue by marketing the drug for the non-approved treatment of another eye condition, blepharitis, according to a lawsuit.
The lawsuit said that Inspire from 2008 through May 2011 misleadingly marketed to doctors purported anti-inflammatory properties of AzaSite that were not supported by substantial evidence or clinical experience.
The marketing caused doctors to prescribe AzaSite for uses not covered by federal healthcare programs, which paid millions of dollars in false claims, the lawsuit said.As part of the settlement, which will go to the United States and various state governments, Inspire made several admissions related to its conduct, Bharara's office said.
Lainie Keller, a Merck spokeswoman, said the company was "glad to put this behind us," adding that the conduct at issue occurred prior to Merck acquiring Inspire, which it later sold to Akorn Inc in 2013.
The case was initiated in 2010 by a purported whistleblower, Jill DeGuzman, under the False Claims Act, and the United States subsequently intervened in it. DeGuzman's lawyer did not immediately respond to a request for comment.
Tuesday, June 16, 2015
Syngenta Expected to Reimburse Losses of Around $2.9 Billion
Viptera, also known as MIR162, was created by Syngenta as a corn seed that prevented corn pests from attacking the crop. It was widely sold for the 2011 crop year. It was during this time that industry participants began to worry about the lack of China Viptera approval. Syngenta, however, expanded sales for the next crop years to allegedly benefit from their monopoly on the MIR162 corn trait.
In 2013, China rejected Viptera entirely, meaning that any corn exports containing even a trace of MIR162 were sent back. This resulted in a wide rejection of U.S. corn, as Syngenta corn had contaminated most of the crops. It was estimated that between $1 billion and $2.9 billion were lost due to Syngenta’s actions.The class action lawsuit states, “Syngenta actively misled farmers, industry participants and others about the importance of the Chinese market . . . the timing of when China was likely to approve MIR162 . . . and its ability to contain the infiltration of [Viptera] into the U.S. corn supply.”
The class action lawsuit also points out that a new GMO corn seed was released for the 2014 crop year that has also not received China approval.
Syngenta Lawsuits
Many Syngenta lawsuits and class action lawsuits have been filed against the company, claiming the defendant misled those involved in the corn industry so they could better profit on their monopoly of MIR162.The plaintiffs in this class action lawsuit include Kenneth Borah, a Texas resident who planted, harvested, and sold Syngenta corn. Plaintiff Scott Lemke, Otis Shinn, William Keller White, Linda Cain Wilson, and the Wright Family LP are also named plaintiffs in this Syngenta lawsuit. All were involved in the corn industry and allegedly suffered from significant financial losses because of Syngenta’s Viptera corn.
Counts in this class action lawsuit include violation of the Lanham Act, negligence, tortious interference with existing and/or prospective business relationships, trespass to chattels, private nuisance, violations of state deceptive and unfair trade practices acts and consumer protection statutes, among other claims.
It is expected that this class action lawsuit will be consolidated into the Syngenta multidistrict litigation in Kansas, where a large number of claims concerning MIR162 have already been consolidated.
Sunday, May 24, 2015
ConAgra Grocery To Settle Salmonella Contamination in Peanut Butter Suit
ConAgra Grocery Products LLC, a subsidiary of ConAgra Foods Inc., today agreed to plead guilty and pay $11.2 million in connection with the shipment of contaminated peanut butter linked to a 2006 through 2007 nationwide outbreak of salmonellosis, or salmonella poisoning, the Department of Justice announced today. ConAgra Grocery Products LLC is based in Omaha, Nebraska, with a manufacturing facility in Sylvester, Georgia.
Acting Associate Attorney General Stuart F. Delery, Principal Deputy Assistant Attorney General Benjamin C. Mizer of the Justice Department’s Civil Division and U.S. Attorney Michael J. Moore of the Middle District of Georgia announced the filing of a criminal information against ConAgra Grocery Products alleging a misdemeanor violation of the federal Food, Drug and Cosmetic Act. The company signed a plea agreement admitting that it introduced Peter Pan and private label peanut butter contaminated with salmonella into interstate commerce during the 2006 through 2007 outbreak. The plea agreement provides that ConAgra Grocery Products will pay a criminal fine of $8 million and forfeit assets of $3.2 million. The criminal fine is the largest ever paid in a food safety case.“As parents, we can make sure that our kids look both ways before they cross the street and wear a helmet when they ride their bikes,” said Acting Associate Attorney General Delery. “But we have to rely on the companies that make their food to make sure it is safe. That’s why the Department of Justice is dedicated to using all the tools we have to ensure the processors and handlers of our food live up to their legal obligations to keep the public’s safety in mind.”
“The safety of the nation’s food supply is a top concern, and every company, large and small, must take appropriate measures to ensure that their products don’t make customers sick,” said Principal Deputy Assistant Attorney General Mizer. “No company can let down its guard when it comes to these kinds of microbiological contaminants. Salmonellosis is a serious condition, and a food like peanut butter can deliver it straight to children and other vulnerable populations.”
In February 2007, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) announced that an ongoing outbreak of salmonellosis cases in the United States could be traced to Peter Pan and private label peanut butter produced and shipped from the company’s Sylvester peanut butter plant. The company voluntarily terminated production at the plant on Feb. 14, 2007, and recalled all peanut butter manufactured there since January 2004. The CDC eventually identified more than 700 cases of salmonellosis linked to the outbreak with illness onset dates beginning in August 2006. The CDC estimated that thousands of additional related cases went unreported. The CDC did not identify any deaths related to the outbreak.
The criminal information, filed in the Middle District of Georgia, specifically alleges that on or about Dec. 7, 2006, the company shipped from Georgia to Texas peanut butter that was adulterated, in that it contained salmonella and had been prepared under conditions whereby it may have become contaminated with salmonella. The company admitted in the plea agreement that samples obtained after the recall showed that peanut butter made at the Sylvester plant on nine different dates between Aug. 4, 2006, and Jan. 29, 2007, was contaminated with salmonella. Environmental testing conducted after the recall identified the same strain of salmonella in at least nine locations throughout the Sylvester plant.
“We, as consumers, take for granted that the food we feed our families is safe,” said U.S. Attorney Moore. “We count on the companies who prepare and package the things we eat to be just as concerned with the product we put in our mouths as they are with the profit they put in their pockets. The proposed criminal fine and sentence in this case should sound the alarm to food companies across the country – we are watching, and we are expecting you to hold yourselves to a standard reflective of the trust that your consumers have placed in you. No more excuses. A lot of people got very sick because of the conduct in this case and we are committed to doing all we can to make sure that does not happen again.”
As part of the plea agreement, the company admitted that it had previously been aware of some risk of salmonella contamination in peanut butter. On two dates in October 2004, routine testing at the Sylvester plant revealed what later was confirmed to be salmonella in samples of finished peanut butter. Company employees attempting to locate the cause of the contamination identified several potential contributing factors, including an old peanut roaster that was not uniformly heating raw peanuts, a storm-damaged sugar silo, and a leaky roof that allowed moisture into the plant and airflow that could allow potential contaminants to move around the plant. As stated in the plea agreement, while efforts to address some of these issues had occurred or were underway, the company did not fully correct these conditions until after the 2006 through 2007 outbreak. In public statements after the 2007 recall, company officials hypothesized that moisture entered the production process and enabled the growth of salmonella present in the raw peanuts or peanut dust.
The company also admitted in the plea agreement that between October 2004 and February 2007, employees charged with analyzing finished product tests at the Sylvester plant failed to detect salmonella in the peanut butter, and that the company was unaware some of the employees did not know how to properly interpret the results of the tests.
“U.S. consumers expect and deserve the highest standards of food safety and integrity,” said Acting Commissioner Dr. Stephen Ostroff of the FDA. “Today’s plea agreement reflects the FDA’s commitment to ensuring the safety of the nation’s food supply and demonstrates that those who risk the health of Americans will be held accountable.”
Following the outbreak and shutdown, the company made significant upgrades to the Sylvester plant to address conditions the company identified after the 2004 incident as potential factors that could contribute to salmonella contamination. The company also instituted new and enhanced safety protocols and procedures regarding manufacturing, testing and sanitation, which it affirmed in the plea agreement it would continue to follow.
This information is according to the Dept. of Justice report!
Tuesday, April 7, 2015
Power Morcellation Causing Uterine Cancer!!
In November of 2014, the U.S. Food and Drug Administration (FDA) issued an updated Safety Communication regarding power morcellation and its alleged link to uterine cancer.
Power morcellation is a type of technique used in laparoscopic surgery. Laparoscopic surgery is a type of surgery wherein surgeons use small, specialized tools to perform the bulk of the procedure inside the patient’s body. This allows surgeons to cut through less healthy tissue, shortening recovery times and making surgery an option for many patients who would be too weak for regular invasive surgery. One of the few downsides to laparoscopic surgery is that in some procedures, like hysterectomies, surgeons must remove large tissue from the body through the small incisions, which has created the necessity for power morcellation.
Power morcellation is a type of laparoscopic procedure where surgeons use a power morcellator to cut tissue into pieces small enough to be removed from the body. But there are growing concerns regarding morcellation cancer, a dangerous side effect of using these convenient medical devices.
The FDA’s November morcellation cancer statement was an update to earlier safety communications from earlier in 2014 on the subject of power morcellation. In this statement, the FDA strongly recommended against the use of power morcellators for hysterectomies because of concerns regarding uterine cancer.
A common reason for the use of power morcellation in hysterectomies is due to the presence of uterine fibroids, a type of benign tumor. However, post-surgical reports have strongly suggested that the many women whom have uterine fibroids may also have malignant cancer cells bound up within the fibroids that have gone undetected. The process of power morcellation is alleged to liberate these cancer cells and spread them within the abdomen, a condition known as morcellation cancer. How far the cancer cells spread is a major predictor of how severe a case of cancer is.
The FDA has advised patients who have had robotic hysterectomies to be vigilant for signs of morcellation cancer and undergo follow-up testing. The FDA has also recommended strongly against the use of power morcellators in hysterectomies and related procedures since this discovery. The FDA, however, stopped short of a full ban on power morcellators, stating that further evidence was needed to justify a full ban. However, the FDA did issue new boxed warning that power morcellators shouldn’t be used to remove uterine fibroids.
Power morcellation lawsuits have been filed by women who developed advanced uterine cancer after their uteruses were removed by power morcellation. Power morcellation lawsuits typically allege that the makers of power morcellators were aware—or reasonably should have been aware—of the risk of morcellation cancer associated with their medical devices. Morcellation cancer lawsuits typically seek to recoup the costs of medical care, lost wages, and other costs allegedly linked to morcellation cancer.
Monday, March 16, 2015
Pharmaceutical Companies Contradicting Official Safety Warnings
According to The Washington Post The Food and Drug Administration is proposing to allow pharmaceutical companies to contradict official safety warnings in sales presentations to customers.
Though an FDA warning can scare off buyers, the new proposal would allow drugmakers to present customers with information that undermines official warnings as long as it comes from a peer-reviewed journal article.
The proposal is supported by the manufacturers, who argue the policy would allow them to give doctors and hospitals the benefits of the latest research.
But the proposal is drawing criticism from public-health advocates, who argue that because individual studies can differ widely in their results, a drug company could easily mislead customers - and possibly endanger patients - by presenting only a selection of new research.
The proposal "seriously undermines FDA authority," Sidney Wolfe, founder of Public Citizen's Health Research Group, wrote the agency. "Its main supporters are drug companies and their associations, all of which would benefit from being allowed and encouraged to sell more drugs by making them seem safer than FDA has judged them to be."
Under the proposal, the FDA would not "object to the distribution of new risk information that rebuts, mitigates, or refines risk information in the approved labeling." Studies must be "well-designed" and "at least as informative as the data sources" the FDA used in generating the official warning.
For example, a drugmaker could present evidence that the severity or frequency of a side effect is less than that suggested by the FDA-approved label. Or it could question whether the drug causes the side effect at all.
Exactly what drugmakers can tell customers has been the subject of regulation and sometimes - when the side effect has led to heart attacks, cancer, or suicide - billion-dollar penalties. But the industry has pushed back in recent years, arguing that under First Amendment, the government cannot curtail their right to disseminate information.
The proposal seems bound to increase drug sales because it is explicitly geared toward undermining the FDA warnings, rather than enhancing them, critics said. The proposal allows the dissemination of information that "rebuts or mitigates" the risk identified by the FDA, or information that "refines" the risk as long as it "does not indicate greater seriousness of the risk."
In a letter to the FDA, the pharmaceutical industry's chief lobbying group, PhRMA, said that while the agency has an "important role in evaluating the safety and efficacy of new medicines . . . we also must recognize the critical need for health-care professionals to receive the most current, accurate and comprehensive scientific information."
"The Constitution's protection of an open and robust exchange of ideas . . . limits FDA's ability to regulate scientific communication," according to the letter signed by PhRMA vice president Jeffrey K. Francer. "PhRMA respectfully submits that FDA should give additional consideration to these First Amendment limitations in issuing final guidance."
Wednesday, March 11, 2015
Specialty Compounding Distributing Adulterated Drugs!
The U.S. District Court for the Western District of Texas entered a consent decree of permanent injunction against Specialty Compounding LLC, Raymond L. Solano III and William L. Swail to prevent the distribution of adulterated and misbranded drugs, the Department of Justice announced today.
The department filed a complaint in the U.S. District Court for the Western District of Texas on Feb. 23, at the request of the U.S. Food and Drug Administration (FDA). According to the complaint, Specialty Compounding manufactured both sterile and non-sterile drugs at a facility in Cedar Park, Texas, and distributed the company’s drugs to hospitals, surgery centers and health clinics in Texas and throughout the United States. As noted in the complaint, Solano is Specialty Compounding’s pharmacist-in-charge and co-owner, and Swail is Specialty Compounding’s Managing Partner and co-owner.
The complaint alleges that Specialty Compounding manufactured a sterile injectable drug product that tested positive for bacterial growth. In addition, according to the complaint, in August 2013, FDA received reports from two Texas hospitals that 17 patients had developed bacterial infections caused by Rhodococcus equi after receiving infusions of calcium gluconate manufactured by Specialty Compounding. Specialty Compounding ceased sterile drug manufacturing operations in August 2013, and recalled all lots of its unexpired sterile drug products distributed since Feb. 1, 2013.
“Specialty Compounding’s manufacturing practices posed a serious risk to the public health,” said Acting Assistant Attorney General Benjamin C. Mizer of the Justice Department’s Civil Division.
“The American public needs to have the confidence that pharmaceutical drugs on the market are safe and effective.”
In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and be bound by a permanent injunction. As part of the settlement, the company and its owners have committed to implementing corrective actions before resuming production of sterile drugs. Specifically, the injunction prohibits Specialty Compounding and its owners from manufacturing, holding or distributing sterile drugs until they comply with the federal Food, Drug, and Cosmetic Act and its regulations. The permanent injunction also provides the defendants cannot resume distribution of sterile drug products until they receive written approval from the FDA that they are in compliance with the remedial provisions of the permanent injunction.
As described in the complaint, the FDA inspected Specialty Compounding’s Cedar Park facility in August and September 2013, and found insanitary conditions and numerous violations of the current good manufacturing practice requirements for drug products. Among other observations, the FDA found that the company was distributing some of their drugs without receiving a valid prescription for an identified individual patient and was introducing into interstate commerce unapproved new drugs and misbranded drugs. In addition, as alleged in the complaint, analyses of samples of a drug product collected by the FDA found bacterial contamination in one of the company’s drugs. The company initiated a recall of all injectable drugs on Aug. 9, 2013.
The government is represented by Trial Attorney Jessica Gunder of the Civil Division’s Consumer Protection Branch, with the assistance of Associate Chief Counsel Melissa Mendoza of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.
The department filed a complaint in the U.S. District Court for the Western District of Texas on Feb. 23, at the request of the U.S. Food and Drug Administration (FDA). According to the complaint, Specialty Compounding manufactured both sterile and non-sterile drugs at a facility in Cedar Park, Texas, and distributed the company’s drugs to hospitals, surgery centers and health clinics in Texas and throughout the United States. As noted in the complaint, Solano is Specialty Compounding’s pharmacist-in-charge and co-owner, and Swail is Specialty Compounding’s Managing Partner and co-owner.
The complaint alleges that Specialty Compounding manufactured a sterile injectable drug product that tested positive for bacterial growth. In addition, according to the complaint, in August 2013, FDA received reports from two Texas hospitals that 17 patients had developed bacterial infections caused by Rhodococcus equi after receiving infusions of calcium gluconate manufactured by Specialty Compounding. Specialty Compounding ceased sterile drug manufacturing operations in August 2013, and recalled all lots of its unexpired sterile drug products distributed since Feb. 1, 2013.
“Specialty Compounding’s manufacturing practices posed a serious risk to the public health,” said Acting Assistant Attorney General Benjamin C. Mizer of the Justice Department’s Civil Division.
“The American public needs to have the confidence that pharmaceutical drugs on the market are safe and effective.”
In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and be bound by a permanent injunction. As part of the settlement, the company and its owners have committed to implementing corrective actions before resuming production of sterile drugs. Specifically, the injunction prohibits Specialty Compounding and its owners from manufacturing, holding or distributing sterile drugs until they comply with the federal Food, Drug, and Cosmetic Act and its regulations. The permanent injunction also provides the defendants cannot resume distribution of sterile drug products until they receive written approval from the FDA that they are in compliance with the remedial provisions of the permanent injunction.
As described in the complaint, the FDA inspected Specialty Compounding’s Cedar Park facility in August and September 2013, and found insanitary conditions and numerous violations of the current good manufacturing practice requirements for drug products. Among other observations, the FDA found that the company was distributing some of their drugs without receiving a valid prescription for an identified individual patient and was introducing into interstate commerce unapproved new drugs and misbranded drugs. In addition, as alleged in the complaint, analyses of samples of a drug product collected by the FDA found bacterial contamination in one of the company’s drugs. The company initiated a recall of all injectable drugs on Aug. 9, 2013.
The government is represented by Trial Attorney Jessica Gunder of the Civil Division’s Consumer Protection Branch, with the assistance of Associate Chief Counsel Melissa Mendoza of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.
Monday, March 9, 2015
Johnson & Johnson Responsibility For Risperdal Limited To 3 Years Retroactive
The South Carolina Supreme Court cut more than half of a $327 million penalty levied on a Johnson & Johnson subsidiary for whitewashing links between its anti-psychotic drug Risperdal and diabetes, limiting claims to a three-year statute of limitations. The state high court cut the penalty to $136 million, limiting claims to three years from a January 2007 tolling agreement between the subsidiary and the state.
The court agreed with Ortho-McNeil-Janssen Pharmaceuticals Inc.’s argument that the trial court erred in granting the state’s motion for a directed verdict on the statute of limitations on claims over alleged labeling violations.
The state supreme court rejected Janssen’s argument that the statute of limitations bars all the state’s claims over the Risperdal labels. The court’s opinion stated further:
We reject Janssen’s position, for Janssen misapprehends the statute of limitations and the concept of continuous accrual of this … cause of action. The labeling claim presents a series of discrete, independently actionable wrongs that are at the core of the typical unfair trade practice action.
Janssen also argued that the statute of limitations applied to claims that it violated the South Carolina Unfair Trade Practices Act by sending “dear doctor” letters that glossed over diabetes risks from Risperdal. The November 2003 “dear doctor” letter spurred the U.S. Food and Drug Administration (FDA) to send a warning letter to Janssen in April 2004, according to the ruling. The court ruled that until the FDA sent its letter, Janssen’s deceptive conduct couldn’t have been discovered before then.
Janssen introduced Risperdal in 1994. Starting in the mid-1990s, evidence began to emerge that Risperdal and other atypical anti-psychotic drugs were associated with diabetes and other metabolic side effects, according to the ruling. The state of South Carolina filed suit in 2007, arguing that Janssen sent misleading letters to more than 7,000 to protect billions of dollars in Risperdal sales. The trial court ordered Janssen to pay $327 million in 2011. States such as Louisiana and West Virginia launched cases against J&J after the FDA ordered the company in 2003 to revise prescribing information for Risperdal to include a warning for an increased risk of diabetes among users
Thursday, February 26, 2015
Ketoconazole-Anti Fungal Medication Should Not Be Distributed
A consumer advocacy group has asked the FDA to immediately withdraw oral formulations of a decades-old fungal medicine over concerns that serious liver damage outweighs “questionable” benefits. And to reinforce its assertion, the consumer group cites an internal FDA memo in which agency staffers two years ago wrote that they did not view the risks associated with ketoconazole as “tolerable.”
The medicine was approved in 1981 to treat various fungal infections and several generic versions are currently available, although the original brand-name medicine is no longer sold. In its petition to the FDA, however, Public Citizen notes the FDA required a so-called black box warning – the most serious safety alert – for the drug in 1983 due to potentially fatal liver damage.
By July 2013, growing concerns prompted the FDA to issue a safety notice that removed several approved uses from the product labeling because of the risk of liver injury, adrenal gland dysfunction and troubling interactions with other medicines. The agency allowed oral versions of the drug to remain available for five fungal infections in the event other treatments fail or are not tolerated.
On the same day, though, the European Medicines Agency recommended all oral formulations be removed from the market over concerns about liver damage. The EMA review committee “could not identify a fungal infection where the level of hepatotoxicity of the drug could be balanced by an adequately substantiated benefit,” according to its report.
What was not previously known is that in January 2013, 14 staffers in the FDA Office of Surveillance and Epidemiology wrote a memo that the “overall benefit-risk assessment… is negative in the context of all of the drug’s labeled indications.” The 48-page review was undertaken after French regulators in 2011 suspended marketing authorization for the tablets due to safety concerns.
“The FDA’s own experts concluded that ketoconazole was too dangerous to remain on the market for any of its approved uses, yet the agency continues to allow hundreds of thousands of prescription for the medication to be filled each year,” says Sammy Almashat of Public Citizen in a statement. The consumer group says 462,000 prescriptions were written in 2014, citing IMS Health data.
An FDA spokeswoman would only say that the agency “will review the petition and respond directly to the petitioner.” We asked the three generic drug makers that sell ketoconazole in the U.S. – Teva Pharmaceuticals, Mylan Laboratories and Taro Pharmaceuticals – for comment, but no one has responded.
Monday, February 23, 2015
Unsafe and Contaminated Medications Released To American's
The Brooklyn (NY) Daily Eagle reported that “the federal
government” has “unsealed a 37-count indictment
charging Med Prep Consulting Inc. with wire fraud and
violations of the Federal Food, Drug and Cosmetic Act
(FDCA).” The company, “together with its owner and
president, Gerald Tighe, and pharmacist-in-charge,
Stephen Kalinoski, allegedly introduced adulterated and
misbranded drugs into the commerce stream and
misbranded drugs with the intent to defraud and mislead
the US Food and Drug Administration (FDA) and Med
Prep’s customers, who consisted of hospitals and other
healthcare providers.” The Daily Eagle added,
“According to the indictment, Med Prep processed
numerous drugs...in purportedly sterile conditions. In an
effort to gain market share, Med Prep repeatedly
misrepresented to its healthcare provider customers that
it adhered to, and in some areas exceeded, industry
standards and laws applicable to sterile drug
preparation.” FDA Commissioner Hamburg said, “The
production of unsafe and contaminated drug products
poses a serious threat to the health of the American
public and cannot be tolerated.”
Thursday, December 11, 2014
FDA Getting Kickbacks For Favorable Evaluations?
“Pharmalot” blog reports on an analysis conducted by the
Journal that revealed that many of the physicians and
other professionals who sit on FDA advisory panels to review
medical devices have financial ties to manufacturers,
although the agency has refrained from disclosing the
relationships. The analysis reviewed panels from 2012
through 2014, and found that of the 122 people who sat on
the panels evaluating devices, one-third received some form
of compensation, including money, research grants or travel
and food from companies. Additionally, almost 10% of FDA
advisers received compensation directly from the specific
company whose product was up for evaluation. The
regulatory agency only disclosed 1% of the connections. FDA
Associate Commissioner Jill Hartzler Warner explained to the
Journal, “If you have a financial interest with a sponsor or a
related firm, but it’s not related to the product at the meeting,
it’s not disqualifying.”
Tuesday, November 25, 2014
Effoxor Recalled For a 2nd Time This Year
Sun Pharmaceutical Industries Ltd. has recalled 68,000 bottles of the antidepressant Effexor (venlafaxine), in the second recall of the drug this year, the Food and Drug Administration (FDA) said.
In both instances, the recalled drug was manufactured at the Indian generic drug maker’s plant in Halol in the state of Gujarat. The drugs were recalled after they failed to dissolve properly in quality tests. The earlier recall, in June, was for 252,000 bottles of Effexor.
Sun Pharma is attempting a $3.2 billion purchase of Ranbaxy Laboratories, an Indian drug manufacturer that has been under scrutiny for manufacturing problems. Ranbaxy has been under export restrictions on its facilities in India, leaving it with only one plant able to manufacture drugs that can be shipped to the U.S. market. The plant in Halol has come under scrutiny from the FDA after a series of recalls of drugs manufactured there, including the diabetes drugs metformin. The FDA inspected Sun Pharma’s plant in September and the agency criticized the company for having “no formalized corrective action plan” to prevent future recalls. If the FDA is not satisfied with Sun Pharma’s plans to resolve the problems found at the plant, it can issue a warning letter, and impose an export ban on the factory.
U.S. regulators are increasing scrutiny of generic drugs made in India, after a series of recalls of prescription and over-the-counter medicines made by Indian drug companies. The FDA is concerned that the drugs fail to meet U.S. standards. Dr. Margaret Hamburg, the FDA commissioner, made a nine-day visit to India in February to meet with pharmaceutical makers to discuss quality and safety issues. Indian companies supply about one quarter of the medicines used in the U.S. In 2013, the FDA banned imports from four plants belonging to Ranbaxy Laboratories Ltd. and Wockhardt Ltd.
Friday, October 3, 2014
Health Canada VS FDA Did They Really Think They'd Win?
Whatever the FDA told Health Canada has had an effect. Days after Health Canada said it would talk to the FDA about Apotex, the regulator has banned the import of finished dosage forms and APIs from two of the drugmaker's plants in India.
Health Canada initially responded to the FDA putting Apotex's finished dose plant in Bangalore, India under import alert by asking the company to quarantine products manufactured at the facility. The quarantine bought Health Canada time to learn why the FDA issued the import alert and formulate its own response. Six days after calling for the quarantine, Health Canada has banned the import of 30 finished products--and a similar number of APIs--that Apotex manufactures at its Bangalore plants.
The regulator has also banned almost 20 APIs--and 50 products in which they are used--from IPCA Laboratories. A common thread links the regulatory actions: Data integrity. "This latest information puts into question Health Canada's trust in the reliability of data that all three plants are required by law to provide to demonstrate the safety and quality of their products," Canadian health minister Rona Ambrose said in a statement.
Reports of data integrity failings at IPCA emerged after FDA visited a plant in July and issued a Form 483. Staff at the IPCA site allegedly falsified temperature records, tweaked integration parameters and overwrote raw data. FDA inspectors visited Apotex around the same time, leading to a warning letter detailing the discarding of undesirable assay results and other data integrity problems.
Thursday, October 2, 2014
Valeant Shortcomings Caught By FDA
Pharma Manufacturing reports that the FDA has
posted a warning letter stating that management at
Valeant Pharmaceuticals failed to properly oversee a
contract manufacturer that supplied it with Sculptra
Aesthetic (injectable poly-L-lactic acid). In particular, the
FDA found no evidence that anyone at Valeant had
reviewed and approved the vendor’s deviation report
after the manufacturer stopped production to fix
problems affecting drug quality. The article says that the
FDA “wants to see evidence Valeant has taken steps to
improve its monitoring of CAPAs and review of supplier
deviation reports.” However, Valeant is confident it can
resolve the issues raised and has already divested
Sculptra Aesthetic as part of a deal with Nestle’s
Galderma unit.
Sculptra Aesthetic, a facial injectable that is marketed to smooth wrinkles. The product competes with Juviderm, which is sold by Allergan. Valeant is trying to buy Allergan, which also sells Botox, for $53 billion in conjunction with Pershing Square Capital Management.
Nonetheless, the letter raises the possibility that Allergan and its supporters may use the agency warning to support their argument that Valeant cutbacks focus too heavily on areas other than marketing, which may jeopardize R&D or patient safety. Earlier this week, the Allergan board reiterated that the Valeant offer is “grossly inadequate and substantially undervalues” Allergan.
We asked Valeant for comment and will update you accordingly. [UPDATE: Shortly after we posted, Valeant released a statement that says, in part, the warning letter "pertains to the management of Valeant's contract manufacturers, rather than Valeant's own internal manufacturing." A Valeant spokeswoman adds that Sculptra Aesthetic was sold shortly after the inspection.]
Monday, September 15, 2014
Drug Shortages Happening So What's the Solution?
A recent trend in drug shortages resulting from manufacturers “experiencing product quality problems” and a lack of supply chain alternatives. Valerie Jensen, associate director of the FDA’s drug shortage program, announced the agency is temporarily leveraging foreign suppliers to alleviate supply constraint. Could this be one of the reasons why we have had so many problems with medication goof ups lately?
Am I the only one concerned about this? So if I am understanding the facts correctly we are in short supply of some meds-so we are going to trust other countries (possibly with some ties to unsavory political choices?) to supply us with them? Why are we then shipping so many medications to other countries again if it only causes us a shortage? Are we just setting ourselves up to be vulnerable to a terror attack through medications?
This is a scary reality they have so many shortages just check it out at : http://www.accessdata.fda.gov/scripts/drugshortages/
This is just a small list:
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