phrma

<div>this is a tag
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</div><div>=</div><div><a href="http://www.alternet.org/drugs/10-worst-big-pharma-company-rip-offs-and-their-plan-keep-gravy-train-rolling">http://www.alternet.org/drugs/10-worst-big-pharma-company-rip-offs-and-their-plan-keep-gravy-train-rolling</a></div><div>
</div><div>When did you become aware of the obscene prices the pharmaceutical industry is charging for drugs? For many it was when a smirking Martin Shkreli, founder of Turing Pharmaceuticals, testified <a href="http://www.usatoday.com/story/money/2016/02/04/martin-shkreli-congressional-testimony-turing-pharmaceuticals-valeant-fda-drug-prices/79808004/" style="color: rgb(241, 96, 44); text-decoration: none;">on the Hill</a> in February about his price hike of the antiparasitic drug Daraprim from $13.50 to $750, after which he called lawmakers “imbeciles” in a tweeted goodbye.For others it was the roll-out of Gilead Sciences hepatitis C drug Sovaldi in 2014 at $84,000 for a 12-week <a href="https://www.washingtonpost.com/news/wonk/wp/2015/12/01/how-an-84000-drug-got-its-price-lets-hold-our-position-whatever-the-headlines/" style="color: rgb(241, 96, 44); text-decoration: none;">course</a> of treatment.“Let’s hold our position whatever competitors do or whatever the headlines,” a Gilead executive said in an internal email, an impressive commitment to price-gouging in the face of public opprobrium. The Senate Finance Committee, in an understatement, <a href="https://www.rawstory.com/2016/03/how-an-army-of-pharma-lobbyists-in-dc-have-locked-in-one-of-the-biggest-ripoff-schemes-in-america/" style="color: rgb(241, 96, 44); text-decoration: none;">said</a> the price did not reflect research and development but a “revenue” push. Forbes writer Avik Roy <a href="http://www.forbes.com/sites/theapothecary/2014/06/17/the-sovaldi-tax-gilead-cant-justify-the-price-its-asking-americans-to-pay/#5df01a1a65e1" style="color: rgb(241, 96, 44); text-decoration: none;">noted</a> the same hepatitis C treatment costs $900 a year in Egypt and that US taxpayers are picking up the tab since most US hepatitis C patients are uninsured, underinsured or imprisoned.Other shocking drug prices include:<ul style="line-height: 25px; background-color: rgb(255, 255, 255);"><li><a href="http://www.nytimes.com/2014/07/19/opinion/joe-nocera-cystic-fibrosis-drug-price.html" style="color: rgb(241, 96, 44); text-decoration: none;">Kalydeco</a> a drug that treats a rare form of cystic fibrosis in patients ages 6 years and older priced at a $300,000 a year.</li><li>Acthar, a drug that treats treat seizures in infants under 2-years-old priced at a $300,000 a year.</li><li>Kadcyla, a breast cancer drug that costs $94,000 for a year.</li><li>Zydelig, a leukemia drug, made by Gilead the (Hep C drug maker) that costs <a href="http://www.thepharmaletter.com/article/nice-yes-for-gilead-s-zydelig-a-new-class-of-drug-for-leukemia" style="color: rgb(241, 96, 44); text-decoration: none;">$57,755</a> a year.</li><li>Hetlioz, a drug that treats non-24 sleep disorder—a problem affecting blind people whose circadian rhythm is off—that costs<a href="http://www.reuters.com/article/us-health-non24-hetlioz-idUSKCN0QG25M20150811" style="color: rgb(241, 96, 44); text-decoration: none;"> $60,000</a> per year.</li><li><a href="http://www.cbsnews.com/news/how-a-sleeping-drug-company-increased-prices-300-without-anyone-noticing/" style="color: rgb(241, 96, 44); text-decoration: none;">Xyrem</a>, a drug that treats narcolepsy for $35,000 per year</li><li>Abilify, a psychiatric drug usually added on to another expensive psychiatric drug, that costs $17, 316 year.</li><li>Praluent, a biologic to lower cholesterol expected to cost over <a href="http://www.fiercepharmamarketing.com/story/sanofi-draws-14600-line-sand-praluent-payer-fight/2015-07-27" style="color: rgb(241, 96, 44); text-decoration: none;">$14,600</a> a year.</li></ul>There are efforts to stop the apparent pharmaceutical industry profiteering and opportunism like pending state bills to <a href="http://www.counterpunch.org/2015/07/27/big-pharmas-profiteers-you-want-us-to-pay-what-for-these-meds/" style="color: rgb(241, 96, 44); text-decoration: none; background-color: rgb(255, 255, 255);">force </a>drug makers to reveal their true costs and allow insurers to refuse payment. The White House is also launching a <a href="http://www.upi.com/Health_News/2016/03/09/New-Medicare-pay-system-aimed-at-lowering-drug-costs/3431457529930/" style="color: rgb(241, 96, 44); text-decoration: none;">new Medicare payment system</a> to stop the incentives for a doctor to use a $2,000 drug when a $50 drug would do. Currently, if doctors buy drugs themselves and administer them in the office, Medicare pays them back with a six percent bonus to cover administrative costs. Under the new program, “Doctors who prescribe a lot of newer, more expensive drugs will earn less than they used to,”<a href="http://www.nytimes.com/2016/03/10/upshot/medicare-tries-an-experiment-to-fight-perverse-incentives.html?r=0" style="color: rgb(241, 96, 44); text-decoration: none; background-color: rgb(255, 255, 255);"> notes</a> The New York Times, as will Pharma. The move was immediately <a href="http://www.nytimes.com/2016/03/10/us/politics/groups-scrutinize-white-house-plan-to-cut-drug-costs-in-medicare.html" style="color: rgb(241, 96, 44); text-decoration: none; background-color: rgb(255, 255, 255);">termed</a> “another troubling example of unelected bureaucrats making decisions behind closed doors,” by Pharma-friendly lawmakers. How dare the government protect our tax dollars?Now Pharma is fighting back. Its lobbying groups, PhRMA, the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization, or BIO. have launched a Washington, DC-focused campaign to keep lawmakers from legislating away its profit party.We Save Lives—Don’t Cut Us Off, Says New CampaignDoes anyone need to be told medicine saves lives? Does anyone need to be told “life is precious”? Apparently so, because the PhRMA/ BIO campaigns depict about 25 patients whose lives were all saved or lengthened by Pharma medicines. “We’re fighting back,” says PhRMA’s new “Hope to Cures: The Value of Biopharmaceutical Innovation and New Drug Discovery” <a href="http://www.fromhopetocures.org/patients" style="color: rgb(241, 96, 44); text-decoration: none;">campaign</a>. “You are not average!”Like “Ask Your Doctor” ads created by the same high budget PR agencies, the videos are full of puppies, sunsets and People Just Like You. We get to meet “Theresa,” diagnosed with thyroid cancer at 57, “Hydeia” suffering from  HIV/AIDS at 31, “Charis” suffering from ankylosing spondylitis at 29 and “Henry” suffering from glutaric acidemia Type 1 at the young age of three. In a BIO video, a voice over <a href="http://www.biopharmadive.com/news/new-emotional-bio-ad-highlights-innovation-in-effort-push-back-on-pricing/414043/" style="color: rgb(241, 96, 44); text-decoration: none;">asks</a>, “how do we place value” on “Another decade with a spouse. A few more years with your best friend. A rich, full life rather than one cut short.”No one wishes the patients depicted anything but well, but the campaign’s meta-message is that if you question Big Pharma’s high prices, you do. The stories deceptively imply that drug regulation—price controls—would threaten the patients’ lives by jeopardizing “research” which is manipulative and untrue. According to <a href="http://www.citizen.org/publications/publicationredirect.cfm?ID=7065" style="color: rgb(241, 96, 44); text-decoration: none;">Public Citizen,</a> Pharma’s actual research is one-fifth of what it claims and taxpayers kick in a big portion of it. Most <a href="http://www.huffingtonpost.com/2012/08/09/pharmaceutical-companies-marketing_n_1760380.html" style="color: rgb(241, 96, 44); text-decoration: none;">reports</a> say Pharma spends a lot more on marketing than research.Nor are most of Pharma’s drugs even life-saving—a <a href="http://www.medicaldaily.com/25-most-popular-pharmaceuticals-do-high-prices-or-label-uses-turn-orphan-drugs-352676" style="color: rgb(241, 96, 44); text-decoration: none;">lot more</a> thyroid, cholesterol, ADHD and acid reflux drugs are sold than cancer drugs, their demand whipped up by direct-to-consumer drug ads. (Some widely marketed drugs like <a href="http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm293330.htm" style="color: rgb(241, 96, 44); text-decoration: none;">statins</a> and <a href="https://www.citizen.org/documents/1964.pdf" style="color: rgb(241, 96, 44); text-decoration: none;">acid </a><a href="http://www.medscape.com/viewarticle/857060" style="color: rgb(241, 96, 44); text-decoration: none;">reflux </a>meds have life-threatening side effects of their own.) PhRMA’s “Hope to Cures” campaign even claims high-priced meds help the economy by creating jobs, like for “sheet metal workers.” Right.Parading sick patients in front of the FDA and state officials who decide drug reimbursements is how Pharma has gotten drugs that cost four, five and six digits approved, usually paid for by taxpayers. Co-opted patients (sometimes called Astroturf because they are not really grassroots) “appear before public and consumer panels, contact lawmakers, and provide media outlets a human face to attach to a cause,” writes <a href="http://www.intrepidreport.com/archives/8897" style="color: rgb(241, 96, 44); text-decoration: none;">Melissa Healy</a> of the Los Angeles Times, “when insurers balk at reimbursing patients for new prescription medications.”Nowhere in the PhRMA PR campaign are actual costs mentioned like the <a href="http://www.lifeextension.com/magazine/2014/4/Unsustainable-Cancer-Drug-Prices/Page-01" style="color: rgb(241, 96, 44); text-decoration: none;">12 cancer drugs </a>that cost above $100,000 a year though many do not<a href="http://www.jsonline.com/news/health/study-two-thirds-of-new-cancer-drugs-dont-extend-life-b99599343z1-334332891.html" style="color: rgb(241, 96, 44); text-decoration: none;"> clearly</a> even extend life. A year on a cocktail of psychiatric drugs can easily<a href="http://www.intrepidreport.com/archives/8897" style="color: rgb(241, 96, 44); text-decoration: none;"> cost</a> $60,000. Instead we hear about rare diseases and rare cancers that presumably would not be cured if lawmakers curtail Big Pharma profits.</div><div>...</div><div> 6/15<div class="entry-content" style="margin: 5px 0px; word-wrap: break-word; color: rgb(33, 43, 74); line-height: 24px;">harmaceutical interests are pushing hard in favor of a bill that could speed up Food and Drug Administration (FDA) approval of new drugs. But the bipartisan <a href="https://www.govtrack.us/congress/bills/114/hr6/text" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">21st Century Cures Act</a>, which was <a href="https://www.govtrack.us/congress/bills/114/hr6" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">approved</a> last month by the the House Energy and Commerce Committee (the <a href="http://energycommerce.house.gov/about/membership" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">members</a> of which have all sponsored the bill) and could reach the House floor by the end of June, has some health advocates up in arms.A <a title="Will the 21st Century Cures Bill Lower Standards for Some Drug Approvals? " href="http://blogs.wsj.com/pharmalot/2015/05/29/will-the-21st-century-cures-bill-lower-standards-for-some-drug-approvals/" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">primary concern</a> is that the bill would encourage the FDA to move away from its reliance on controlled trials — and specifically those using randomization — as the main marker for determining whether a drug is safe and effective enough to go on the market. Instead, it suggests that “clinical experience,” which includes observational study, patient anecdotes, and other such methods, be given more consideration. Clinical experience is and has been used as supplemental evidence by the FDA, but not as the primary method for determining a drug’s safety and efficacy.Dr. John Powers, the former lead medical officer for antimicrobial development and resistance issues at the FDA and a member of the National Physicians Alliance’s FDA task force, said that such a method was akin to using “Star Trek medicine mentality” that relies on unsubstantiated belief instead of valid scientific evidence.“The number of ways patients can be different from each other that can influence patient-centered outcomes independent of treatment is innumerable,” Powers told OpenSecrets Blog, adding that with clinical experience, one “can’t take into account all complexities that happen in the human body.”The 21st Century Cures initiative was <a title="A Path to 21st Century Cures" href="http://energycommerce.house.gov/press-release/path-21st-century-cures" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">launched</a> on April 30, 2014 by House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) and committee member Diana DeGette (D-Colo.), and a <a title="21st Century Cures: A Call to Action" href="http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/analysis/21stCenturyCures/20140501WhitePaper.pdf" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">white paper</a> on the initiative was <a title="Roundtable and White Paper A Part of 21st Century Cures - See more at: http://energycommerce.house.gov/press-release/roundtable-and-white-paper-part-21st-century-cures#sthash.ZuBHDSXl.dpuf" href="http://energycommerce.house.gov/press-release/roundtable-and-white-paper-part-21st-century-cures" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">released</a> the following day. The legislation, which was introduced by Upton last month (with a<a href="http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/114/Analysis/Cures/20150127-Cures-Discussion-Document.pdf" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">discussion document</a> <a title="21st Century Cures Legislative Phase Now Underway - Continued Feedback Sought as #Cures2015 Begins in Earnest - See more at: http://energycommerce.house.gov/press-release/21st-century-cures-legislative-phase-now-underway-continued-feedback-sought-cures2015-begins-in-earnest#sthash.BUwJTKYW.dpuf" href="http://energycommerce.house.gov/press-release/21st-century-cures-legislative-phase-now-underway-continued-feedback-sought-cures2015-begins-in-earnest" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">released</a> in January), currently has 138 sponsors — most of whom boast the <a href="http://www.opensecrets.org/industries/indus.php?cycle=2014&ind=H04" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">pharmaceuticals/health products</a> industry as one of their top 20 contributors in the 2014 election cycle.That includes all of the bill’s original sponsors: $302,700 for <a href="http://www.opensecrets.org/politicians/industries.php?cycle=2014&cid=N00004133&type=I" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">Upton</a>, $184,500 for <a href="http://www.opensecrets.org/politicians/industries.php?cycle=2014&cid=N00001633&type=I" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">Joe Pitts </a>(R-Pa.), $174,072 for <a href="http://www.opensecrets.org/politicians/industries.php?cycle=2014&cid=N00000781&type=I%20" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">Frank Pallone</a> (D-N.J.) — the Committee’s ranking member, $112,949 for <a href="http://www.opensecrets.org/politicians/industries.php?cycle=2014&cid=N00006134&type=I%20" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">DeGette</a> and $72,044 for <a href="http://www.opensecrets.org/politicians/industries.php?cycle=2014&cid=N00005870&type=I%20" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">Gene Green</a> (D-Texas).Pallone’s district contains the headquarters of pharmaceutical giant <a href="http://www.opensecrets.org/lobby/clientsum.php?id=D000000386&year=2014" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">Johnson & Johnson,</a> whose PAC <a href="http://www.opensecrets.org/politicians/contrib.php?cid=N00000781&cycle=2014&type=I&newMem=N&recs=100" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">gave</a> him $10,000 in the last election cycle.The company has <a href="http://www.opensecrets.org/lobby/clientissues_spec.php?id=D000000386&year=2015&spec=HCR" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">lobbied</a> on the initiative as well — as have numerous pharmaceutical companies and trade groups, which bring vast resources to bear on anything going on in Washington that might affect their interests. In fact, the pharmaceuticals/health products industry consistently <a href="http://www.opensecrets.org/lobby/top.php?showYear=2015&indexType=i" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">spends more on lobbying</a> than any other interest group. Big spenders over the past two years that have mentioned the initiative most frequently in lobbying reports include drug companies <a href="http://www.opensecrets.org/lobby/clientsum.php?id=D000000215&year=2015" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">Sanofi</a>(which spent nearly $6 million on lobbying in 2014, $1.8 million in the first quarter of 2015), <a href="http://www.opensecrets.org/lobby/clientsum.php?id=D000043112&year=2015" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">AstraZeneca PLC</a> ($2.9 million in 2014, $503,000 in 2015) and<a href="http://www.opensecrets.org/lobby/clientsum.php?id=D000000133&year=2015" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">GlaxoSmithKline</a> ($4.4 million in 2014, $1.7 million in 2015) — as well as industry associations such as the <a href="http://www.opensecrets.org/lobby/clientsum.php?id=D000024369&year=2015" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">Biotechnology Industry Organization</a> ($8.3 million in 2014, $2 million in 2015) and the <a href="http://www.opensecrets.org/lobby/clientsum.php?id=D000000504&year=2015" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">Pharmaceutical Research & Manufacturers of America</a>(PhRMA) ($16.6 million in 2014, over $5.4 million in 2015).Both name brand and generic drug companies, often at odds, want the bill to go through. The <a href="http://www.opensecrets.org/lobby/clientsum.php?id=D000026186&year=2015" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">Generic Pharmaceutical Association</a>‘s President and CEO Ralph G. Neas referred to it in a <a href="http://www.gphaonline.org/gpha-media/press/statement-by-ralph-g-neas-president-and-ceo-gpha-regarding-21st-century-cures" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">press release</a> as a “bipartisan achievement that should enhance the drug approval process and significantly boost critical research and development efforts.”In the first quarter of 2015, 208 entities lobbied on the initiative, a list with countless pharmaceutical and biotechnology-centered companies.A spokeswoman from the House Energy and Commerce Committee maintains that safety will not be compromised by the bill. “Modernizing health care innovation and maintaining the highest standards of safety and efficacy are not mutually exclusive,” she said. “This is why the committee brought every key player to the table — including the FDA, the NIH, top scientists, researchers, and thought leaders — for more than a year to carefully develop this vital legislation.”Former FDA commissioner Andrew von Eschenbach, who served under former President George W. Bush, along with Manhattan Institute scholar Paul Howard, wrote in support of the bill in the <a title="21st Century Cures Legislation: Embracing the Future of Medicine" href="http://morningconsult.com/opinions/21st-century-cures-legislation-embracing-the-future-of-medicine/" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">Morning Consult</a> this week. “Armed with massive computing power and modern analytics, advanced diagnostics like functional MRIs, and electronic medical records, researchers can now compile massive databases containing genomic variants and patient health outcomes that can allow them to rapidly identify, test, and validate hypothesis about effective disease fighting strategies,” von Eschenbach and Howard write. “With this information in hand, it is unnecessary and perhaps even unethical to demand that we conduct traditional large, blinded and randomized controlled trials for precision medicines supported by a variety of mechanistic and pre-clinical data.”But two other former FDA commissioners have concerns with 21st Century Cures — even though it does <a title="FDA overhaul bill moves ahead after funding deal" href="http://www.modernhealthcare.com/article/20150523/MAGAZINE/305239960/fda-overhaul-bill-moves-ahead-after-funding-deal" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">allot </a>over $10 billion to the National Institutes of Health (NIH) and $550 million to the FDA over five years. Margaret Hamburg, a recently departed commissioner, <a title="FDA's Hamburg, on her way out, blasts bill aimed at speeding innovation" href="http://www.modernhealthcare.com/article/20150327/NEWS/150329910" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">said </a> in a March speech, that “there’s a misperception that you might be able to speed up innovation by lowering the standards for safety and efficacy, and I think that would be a terrible mistake that would not only just damage patients, but industry as well.” David Kessler, who served as commissioner during both the George H.W. Bush and Bill Clinton administrations, wrote this month in a joint <a title="Don’t Weaken the F.D.A.’s Drug Approval Process" href="http://www.nytimes.com/2015/06/11/opinion/dont-weaken-the-fdas-drug-approval-process.html" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">New York Times</a> op-ed that the act “could substantially lower the standards for approval of many medical products, potentially placing patients at unnecessary risk of injury or death.”And the <a href="http://center4research.org/about-us/" target="blank" style="color: rgb(17, 123, 184); text-decoration: none; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">National Center for Health Research</a>, a think tank involved in research “used to encourage new, more effective programs, policies, and medical treatments,” is also worried about the legislation. In addition to uneasiness about relying on clinical experience, other concerns include parts of the Act that would allow new drugs to be approved for select individuals based on preliminary data, create financial incentives for the use of new antibiotics, and could allow companies to use limited evidence in order to get FDA approval for new medical devices.So far, it’s only in the House where the two sides are tussling over whether the bill is a salutary prescription; no companion measure is yet pending in the Senate.Correction, 6/16: This post has been corrected to reflect the fact that formal 21st Century Cures legislation was not introduced until the second quarter of 2015; the companies mentioned lobbied on the initiative.
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