- E-mails reveal concerns about Theranos’s FDA compliance date back years (washingtonpost.com)Surprise: Theranos CEO Says Company Is Doing More Tests Than Ever (forbes.com)A comprehensive guide to Theranos’s troubles and what it means for you (washingtonpost.com)Hot Startup Theranos Has Struggled With Its Blood-Test Technology (req sub) (wsj.com)
Years before Theranos…came under harsh public scrutiny in October, a military official raised concerns that the secretive company was violating federal law…E-mail correspondence obtained by the Post reveals that an official evaluating Theranos’s signature blood-testing technology for the Department of Defense sounded the alarm in 2012 and launched a formal inquiry with the Food and Drug Administration about the company’s intent to distribute its tests without FDA clearance — a problem that has resurfaced this year, leading Theranos to temporarily stop offering almost all of its tests...In October, a Wall Street Journal investigation revealed the company was running most of its tests on devices made by other firms instead of its own “breakthrough” technology. The Journal reported that former Theranos employees and executives of Safeway had questioned the accuracy of the tests.
- Law for rare disease drugs needs revamping, researchers say (statnews.com)The Orphan Drug Act: Restoring the Mission to Rare Diseases.(req sub) (ncbi.nlm.nih.gov)
…the Orphan Drug Act was passed to give drug makers incentives to create medicines for rare diseases, which are defined as maladies that affect fewer than 200,000 people. The incentives include tax credits and seven years of marketing exclusivity. Since then, more than 400 orphan drugs have been approved by the Food and Drug Administration. Last year, though, 41 percent of all FDA approvals were for orphan drugs. And sales of orphan medicines, which carry high price tags, are forecast this year to total $107 billion…team of researchers argues that drug makers are exploiting loopholes that allow them to widen the market for such drugs and distorting the original purpose of the law. We spoke with Martin Makary, a cancer surgeon and professor of health policy at Johns Hopkins School of Medicine…
- FDA says Novartis plant in India backdated data and withheld info (statnews.com)Regulating India's Generic Drug Industry (podcast 13:46) (soundcloud.com)
Last month, Novartis disclosed that it received a warning letter from the Food and Drug Administration about manufacturing issues at two facilities in India that are operated by its Sandoz generic drug unit…At the time, the company noted it was working closely with the FDA to resolve the problems. But Novartis never actually specified what bothered the agency. Now, the warning letter has been posted on the FDA website, and the infractions are concerning, especially given that the plants are run by one of the world’s largest suppliers of generic medicines…The disclosure comes amid ongoing FDA scrutiny of overseas manufacturing plants, particularly in India, where a string of drug makers has failed inspections and had products banned from the US. The Indian pharmaceutical industry is furious that the agency appears to be singling out its ranks for infractions; however the Sandoz letter indicates the FDA is not confining its reviews to India’s domestic drug makers…A key issue that alarmed the agency during its August 2014 inspections was the integrity of the data Sandoz was collecting…“Backdating … records is unacceptable,” the FDA wrote in its Oct. 22 warning letter. The agency also expressed concern that Sandoz failed to demonstrate the extent to which such practices may be widespread and — this is significant — whether previous data is even reliable.
- Why FDA Should Oversee Laboratory Developed Tests (blogs.fda.gov)The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies (fda.gov)Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) DRAFT GUIDANCE (fda.gov)Theranos isn’t the only diagnostics company exploiting regulatory loopholes (theverge.com)
Today FDA is issuing a report that illustrates the real and potential harms to patients and to public health from certain laboratory developed tests (LDT) – tests that are designed, manufactured and used in a single laboratory…But times have changed. LDTs have increased in complexity and availability and are now frequently used to diagnose common, serious medical conditions, including cancer and heart disease, with potentially greater impact on patients...LDTs are still under a general policy of enforcement discretion. That means they have rarely undergone FDA review to determine whether they are accurate, reliable, and provide clinically meaningful results...FDA’s own adverse event reporting databases rarely capture problems associated with a faulty LDT...the Agency was able to pull together 20 case studies based on information available in the public domain that show how lack of LDT oversight may be causing or is causing significant harm to patients…FDA has proposed to step up our oversight of LDTs. We issued a draft guidance last year which we’re currently working to finalize, that proposes to phase in enforcement of premarket review requirements for LDTs. FDA oversight would help ensure that tests are supported by rigorous evidence, that patients and health care providers can have confidence in the test results, and that LDTs have more scientifically accurate product labeling.
- FDA delays proposed rule on safety warnings for generic drugs again (statnews.com)Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (federalregister.gov)
For the second time, the Food and Drug Administration has delayed a controversial rule for updating generic drug labeling that would allow generic drug makers to independently update safety warnings, something only brand-name drug makers can currently do before receiving regulatory permission…the agency said the rule will be published in July 2016…The delay came amid push-back from the pharmaceutical industry, as well as some congressional lawmakers who questioned whether the agency has the authority to issue such a rule…FDA said it wants to “create parity” between brand-name and generic drug makers…generic drug makers have not been required to run tests to prove their medicines are the same as brand- name drugs and, therefore, have not had to upgrade labels with safety information…the generic trade group has argued the FDA rule could add $4 billion to the nation’s health care bill because regulatory requirements and litigation costs would eventually force manufacturers to raise prices.
- FDA to Announce Next Steps in Essure Review (raps.org)Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study (bmj.com)
Food and Drug Administration says it plans to make an announcement on the birth control device Essure in February 2016, after the agency completes a "high priority" review of the device's safety…The agency is also considering a recent MDEpiNet study…found women who received Essure had a "more than 10-fold higher risk of undergoing reoperation," when compared to women who had laparoscopic sterilization…Essure is a permanent birth control device…marketed by Bayer…Essure was first approved...in 2002 under FDA's premarket approval process…In recent years Essure has been surrounded by controversy as patients and activists have claimed the device has caused serious and debilitating side effects… Others have claimed the device is not as effective as it claims…in November, Representative Mike Fitzpatrick introduced a bill titled the E-Free Act directing FDA to pull Essure's PMA within 60 days of the bill's passage. So far the bill has four co-sponsors, including Reps. Marsha Blackburn, Christopher Smith and Lou Barletta.
- Bumper haul of expensive new drugs heads to U.S. and Europe (reuters.com)
Food and Drug Administration has so far approved 37 novel drugs in 2015, more than the 34 that had been cleared by this stage a year ago and just short of 2014's final total of 41…European Medicines Agency is also waving through more products, recommending a total of 84 new medicines so far, up from 75 in the first 11 months of 2014…The brisk pace of new arrivals over the past two years reflects improved productivity in drug research labs and a change of pace by regulators, who have committed to speed up the process of getting life-saving treatments to patients, especially in cancer…The science has got better and we seem to be finding more molecules that are showing material improvements…the rapid pace of new drug launches is forecast to continue, with 225 new drugs expected to be approved between 2016 and 2020…Drug companies argue they need to make decent profits to pay for the billions of dollars needed for drug research. Many companies also have extensive low-cost or even free access schemes for patients who cannot afford their medicines… For healthcare systems in the developed world, paying for such pricey medicines is a challenge - but for many patients in poor countries they will remain out of reach, reflecting the economic realities of drug development.
- Exclusive: Investments give lawmakers personal stake in biotech, health care (statnews.com)
The congressman didn’t mince words when the Food and Drug Administration aired a plan to regulate diagnostic tests at a recent hearing. That could slow approvals, Representative Christopher Collins warned: “You run the risk of causing people to die.”…What Collins didn’t say at the hearing was that he has a financial stake in the issue: He co-founded a company that makes components for those tests. And he retains an ownership stake in that company, an asset he values at between $5 million and $25 million…Welcome to Congress, where such arrangements are legal — and to many critics, deeply disturbing…analysis of thousands of pages of congressional disclosure forms found that about 30 percent of senators and 20 percent of representatives held assets in biomedical and health-care companies, or in specialty funds set up to invest in those industries, during 2014…Some of the most aggressive congressional investors in the biomedical sector also sit on key committees, such as the House Judiciary Committee, which has jurisdiction over patent law, or the House Energy and Commerce Committee, which oversees the Food and Drug Administration and works on many issues of critical importance to the industry, including drug regulation, research funding, and taxes on medical devices…Members of Congress are not required to recuse themselves from voting on bills that could affect their personal finances, unless they would be the primary beneficiary of the legislation.
- CDC calls for increased PrEP awareness for high-risk patients (drugstorenews.com)Daily Pill Can Prevent HIV (cdc.gov)
New data from the Centers for Disease Control and Prevention has the organization urging providers to education themselves about the potential of pre-exposure prophylaxis drugs (PrEP) that can significantly reduce the risk of contracting HIV…Though the once-daily pill —which was approved by the Food and Drug Administration in 2013 and marketed as Truvada (tenofovir/embtricitabine) — can reduce risk of HIV transmission through sexual contact by 90% and the risk among injected drug users by 70%, new information shows that one-in-three primary care doctors and nurses haven’t heard of PrEP…“PrEP isn’t reaching many people who could benefit from it, and many providers remain unaware…“With about 40,000 HIV infections newly diagnosed each year in the U.S., we need to use all available prevention strategies.”
- FDA approves Adapt Pharma’s nasal spray for opioid overdose treatment (reuters.com)
Food and Drug Administration approved the first-ever nasal spray emergency treatment for opioid overdose…The spray, developed by privately held Adapt Pharma Ltd, uses naloxone, a drug used to treat opioid overdose for nearly 45 years but approved only in injectable forms…The treatment…is expected to have wide coverage under health insurance with affordable co-pays…Group purchasers, such as law enforcement, fire fighters, departments of health, local school districts, colleges and universities, and community-based organizations will be able to purchase the spray at a discounted price of $37.50 per 4 mg device…