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GlaxoSmithKline is recalling a "small" number of batches of its Bactroban antibiotic following a harsh rebuke from US regulators about contamination at a key plant. The move comes after the US Food and Drug Administration sent a stern warning letter late last month to the drug maker about a host of quality-control problems at the facility, which is located in...the United Kingdom...The FDA issued its missive...and found what it called "significant deviations" from good manufacturing practices...The FDA...also noted that the drug maker provided an inadequate response, despite having halted production of the antibiotic and recalling product from wholesalers last year...The letter is the latest attempt by the FDA to bolster the viability of the pharmaceutical supply chain amid a rash of quality-control gaffes. The agency has been attempting to crack down on manufacturers and ingredients suppliers — particularly in India and China — in response to various episodes that led to product recalls and import bans...

One of the experts, Dr. Gregory Terman, said he was dismissed Tuesday afternoon by phone. He said he was told the decision was made because his nonprofit group, the American Pain Society, receives funding from drugmakers...A group advising the Food and Drug Administration on medical issues abruptly dropped four experts from a panel on prescription painkillers after concerns emerged about apparent ties to the pharmaceutical industry...Federal advisers are supposed to be vetted for financial ties that can influence their judgment. Senator Ron Wyden of Oregon sent a letter Friday to the academies’ leadership noting that two of the panel nominees had also served in professional societies that receive funding from drugmakers. Wyden has protested industry influence on federal expert panels before.

...one drug maker has failed to provide the Food and Drug Administration with a required study about the effect its powerful painkiller might have on teenagers...At issue is Xartemis XR (oxycodone/acetaminophen), which Mallinckrodt Pharmaceuticals received regulatory approval to sell two years ago. At the time, the company was also required to conduct a so-called post marketing study to determine its safety in youngsters between 12 and 17 years old…as of June 24, the company blew past a March 31 deadline for submitting its pediatric assessment. The drug maker also failed to respond to an April 25 "noncompliance" letter for which the FDA provided a new 45-day deadline to either submit the data or request an extension...The assessment was required under the Pediatric Research Equity Act...What happens if the company fails to comply and submit the data to the FDA? According to federal law, the agency could determine that Xartemis XR is misbranded. That would not lead to a product withdrawal, but the FDA could pursue an injunction or seizure proceedings...

...two Chinese companies　with ties to Western drugmakers have been called on the mat to account for problems in their manufacturing. The FDA has issued warning letters to plants operated by Shanghai Desano Chemical Pharmaceutical and Chongqing Lummy Pharmaceutical, slamming them both for manipulating testing and turning in falsified batch test results on APIs...

• Shanghai Desano Chemical Pharmaceutical - FDA...criticized the facility for conducting "unofficial" tests of drug batches that it kept out of its official record...also disturbed by finding many electronic logs of production deviations in a folder titled "GMP Anomalies" that had never been investigated…
• Chongqing Lummy Pharmaceutical...FDA...warning letter slams the drugmaker for widespread and serious data manipulation of batch analyses...In one egregious case, the FDA...an analyst set the gas chromatography personal computer clock back to make it appear as if testing had been done...7 months earlier. The analyst then performed 5 injections to produce falsified results for long-term stability for a finished API lot, deleted four and reported only the results of the final injection as passing in the quality-control...

People naturally assume that the medicines prescribed by doctors are tightly regulated and have been approved by the Food and Drug Administration, but that’s not true. Loopholes in the regulations that set the standards for a practice called "drug compounding" have enabled dangerous products to injure and kill untold numbers of unsuspecting patients...FDA exempted compounding pharmacies from many of the manufacturing, labeling and other requirements other drugs are subject to...FDA does not require pharmacies to report adverse events associated with compounded drugs...the FDA has the authority to take action when compounding pharmacies violate the law and can act quickly if there is an "imminent hazard to public health," regulators have failed in several critical areas, including inspecting pharmacy records, enforcing quality standards and being able to identify the facility that made a particular drug...In order to create an acceptable risk-benefit paradigm for drug compounding, FDA needs to increase its scrutiny over compounding pharmacies. When a pharmacy is allowed to morph into a large-scale drug manufacturer without adequate oversight, it’s a matter of life and death.

Less than one month following Walgreens decision to terminate its relationship with Theranos, the blood-testing lab on Thursday announced that the Centers for Medicare & Medicaid Services has revoked the company's CLIA certificate, among other sanctions. The revocation of Theranos' CLIA certificate precludes the owners and operators of Theranos from owning, operating or directing a lab until at least July 2018...In addition to the revocation of Theranos' CLIA certificate, the full list of CMS sanctions include:

• Limitation of the laboratory’s CLIA certificate for the specialty of hematology;
• A civil money penalty;
• A directed portion of a plan of correction;
• Suspension of the laboratory’s approval to receive Medicare and Medicaid payments for any services performed for the specialty of hematology; and
• Cancellation of the laboratory’s approval to receive Medicare and Medicaid payments for all laboratory services.

A federal appeals court...that biosimilar makers must always notify their brand-name rivals six months before launching expensive biologic medicines. The decision may have a significant impact on near-term health care costs, because it will effectively delay competition for these pricey drugs...The stipulation is designed to give a brand-name company time to determine what, if any, patent challenges can be pursued before a biosimilar is launched. In a closely watched case last year, the federal appeals court already ruled that biosimilar companies must wait until they actually receive Food and Drug Administration approval before giving 180-day notice to a brand-name rival...today’s decision will answer an important policy question and serve as a broader benchmark for the entire pharmaceutical industry going forward...A great deal is at stake for patients and payers because biosimilars are estimated to save as much as $44 billion in US health care costs over the next decade. Many insurers and analysts forecast that biosimilars will cost 10 percent to 30 percent less than brand-name biologics, although the number is a moving target, given that companies raise biologics prices to anticipate competition...

Thanks to a pair of pricey hepatitis C treatments, Gilead Sciences has become one of the world’s largest drug makers. Since 2013, revenues have tripled to more than $32 billion and profits grew sixfold, exceeding $18 billion. But beyond successful marketing of lifesaving medicines, the company has excelled in another way — using loopholes to avoid paying billions of dollars in taxes...By transferring certain key assets to Ireland, Gilead was able to take advantage of tax laws that allowed some US sales to be shifted overseas and yield a significantly lower tax rate. Those overseas profits, meanwhile, mushroomed to $28.5 billion, and Gilead was able to escape paying $9.7 billion in US taxes last year, according to a new report...

Alibaba Health Information Technology Ltd…the subsidiary of China’s biggest e-commerce operator is attempting to revive its fortunes by tapping new areas of growth -- like consumer safety...China...scrapped plans to implement a compulsory drug coding system intended to identify counterfeit medicines that would have used a platform developed by Ali Health. The Alibaba Group Holding Ltd. subsidiary says it is now using the same technology to build a commercial tracking platform that will have wider applications beyond medicines...Ali Health’s new system could be used to track the origins of products such as baby formula, farm produce and even wine for Chinese consumers concerned about food safety…Ali Health is currently talking to partners to expand use of the technology, and continues to run the existing drug tracking system for the government while awaiting a final decision. The China Food & Drug Administration suspended the electronic coding system earlier this year for use in the drug industry as it made draft amendments to existing rules, allowing the use of other methods to track medicines back to their origin...

Two compounding pharmacists from Alabama will spend a year in prison for distributing tainted drugs... The adulterated drugs were compounded at Advanced Specialty Pharmacy, which did business as Meds IV... David Allen...and William Timothy Rogers...pleaded guilty...to 2 misdemeanor violations of the Federal Food, Drug and Cosmetic Act...the 2...were sentenced to 12 months and 10 months in prison, respectively...also...1 year of supervised release after they get out of prison, and they’ll each have to pay a $5000 fine...Meds IV compounded...its own amino acid solution, then mixed it with other ingredients to create TPN (Total Parenteral Nutrition)...The amino acid solution happened to be contaminated with Serratia marcescens, and the TPN was prepared, packed, or held in insanitary conditions...the amino acid was prepared by Meds IV outside a laminar airflow workbench and was kept unrefrigerated, in a room that was not sterile, in a large pot sitting on the floor, sometimes overnight, before it was sterilized and used...Nine patients developed bloodstream infections and died, while others developed S. marcescens bloodstream infections but survived.