- To avoid shortages, FDA allows imports from 8 drug plants banned for quality shortfalls (fiercepharma.com)
With the vast majority of drugs and drug ingredients being manufactured outside the U.S., the FDA has had to step up its international oversight and often ban products from plants that don’t meet its standards. But the FDA also has found itself increasingly having to walk a tightrope between drug safety and drug availability...Because of the nature of the business, with companies in China or India often being a primary source of essential drugs, the FDA sometimes must exempt products and allow imports from plants that it believes have a poor record. Since 2013 the FDA has allowed 8 plants whose products are otherwise banned from the U.S. to go ahead and import some drugs or ingredients to avoid shortages, according to FDA Import Alert records.
- Painkiller panel drops experts linked to pharmaceutical industry (financialexpress.com)
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.
- FDA warnings slam Chinese drugmakers, including ViiV partner (fiercepharma.com)
...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...
- Drug makers pay $67 million for misleading docs about cancer drug survival data (statnews.com)
Two drug makers — Roche’s Genentech and OSI Pharmaceuticals — announced a deal...to pay $67 million to resolve charges they made misleading statements about the effectiveness of the Tarceva drug to treat non-small cell lung cancer...between 2006 and 2011, the companies gave promotional materials to oncologists that included misleading and overstated survival data to influence prescribing. The drug was originally approved by the US Food and Drug Administration as a second-line or back-up treatment, but the inflated data prompted some doctors to use Tarceva as a first choice, which boosted usage...the feds contend the companies violated the False Claims Act, because federal health care programs, such as Medicare and Medicaid, overpaid for the medicine…The infractions came to light thanks to a whistleblower lawsuit that was filed by Brian Shields, a former Tarceva senior product manager. His 2011 lawsuit described an elaborate scheme that was used to bolster Tarceva prescriptions, including kickbacks purportedly paid to physicians...
- European regulator recommends suspending numerous drugs over clinical trial problems (statnews.com)
The European Medicines Agency...recommended suspending the sale of dozens of generic medicines — many of which are sold by Novartis and Teva Pharmaceuticals — over concerns about "flawed" studies that were conducted by an Indian clinical research organization...The move comes three months after the US Food and Drug Administration alerted an untold number of drug makers of problems at the Semler Research Center...in Bangalore. An inspection...found "significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples."...the World Health Organization had issued a notice to Semler for the same reasons...regulators in each EU country will have to determine the extent to which specific medicines that were tested by Semler are critically needed before proceeding with suspensions. The EMA noted there is no evidence, to date, that any patients were harmed or that any of the drugs were not effective.
- IACP’s 2016 Compounders on Capitol Hill Report (iacprx.org)
IACP Members Go to the Hill with Three Actionable Asks
This year, IACP went to the Hill with three Asks, each with a Congressional action item. IACP and its legislative team have worked tirelessly for the past year emphasizing FDA should be implementing DQSA (Drug Quality and Security Act) according to congressional intent!
- Issue #1 Support Pharmacists: Sign the Bipartisan Letter to FDA Led by Representatives Chris Stewart and Henry Cuellar.
- Issue #2 Support Letter to Chairman Chaffetz and Ranking Member Cummings to Request House Oversight and Government Reform Hearings on FDA's Implementation of DQSA.
- Issue #3 Support Pharmacists: Sign the Senate Letter to FDA Regarding Office-use.
- AstraZeneca sues FDA to prevent generic versions of Crestor (statnews.com)
Drug makers generally don’t complain when regulators widen the market for their medicines. But AstraZeneca filed a lawsuit...claiming the Food and Drug Administration is on the verge of illegally broadening the indication for its best-selling Crestor cholesterol pill, and the move would unfairly allow generic competition...The argument, which the company also made late last month in a citizen’s petition, hinges on the interpretation of federal law governing product labeling. Depending upon the outcome, AstraZeneca may either maintain a monopoly on Crestor for another seven years or face lower-cost rivals to a key revenue stream when the Crestor patent expires on July 8...the drug maker won FDA approval to sell Crestor to treat children with a rare genetic disorder called homozygous familial hypercholesterolemia...Under the Orphan Drug Act, the company was awarded an additional seven years of marketing exclusivity for Crestor, but only for treating this particular rare...disease...Several generic companies are lined up to sell a version of Crestor. AstraZeneca argues that a generic must include all pediatric labeling information approved for the corresponding brand-name drug. The company filed its lawsuit over concerns that the FDA will, instead, rely on a decision it made last year allowing generic companies to exclude certain information, so long as a safety risk is not created...AstraZeneca...believes federal law entitles the company to an additional exclusivity period of seven years for Crestor in the US...the American Journal of Clinical Oncology, a team of researchers argued that drug makers are exploiting loopholes in the Orphan Drug Act that allow them to widen the market for such drugs and distorting the original purpose of the law.
- FDA sends stern warning to Glaxo over contamination at a penicillin plant (statnews.com)
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...
- Drug maker is warned over missing study about child opioids use (statnews.com)
...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...
- FDA seeks suspension of 4,402 illegal prescription drug websites (reuters.com)
The U.S. Food and Drug Administration said...along with international authorities, has formally sought to suspend 4,402 websites that illegally sell potentially dangerous, counterfeit or unapproved prescription drugs to U.S. consumers...The move is part of a global effort being led by the INTERPOL...to identify the makers and distributors of illegal prescription drugs...the FDA said it has also issued warning letters to operators of 53 websites that illegally sell unapproved and misbranded prescription drug products to U.S. consumers...Preliminary findings...showed U.S. consumers had purchased certain unapproved drug products from abroad to treat depression, narcolepsy, high cholesterol, glaucoma, and asthma, among other conditions...