Breaking News
June 24, 2018 - Blood type O patients may have higher risk of death from severe trauma
June 24, 2018 - New studies on molecular and cellular proteomics
June 24, 2018 - Algorithm predicts dangerous low blood pressure during surgery
June 24, 2018 - Herpes may play role in pathogenesis of Alzheimer’s
June 24, 2018 - Inaccurate measurement of sodium intake may account for paradoxical results, study suggests
June 24, 2018 - Aquinnah Pharmaceuticals wins NINDS grant to advance novel therapies for ALS
June 24, 2018 - Study upends conventional view of opioid mechanism of action
June 24, 2018 - Floppy eyelids may be sign of sleep apnea, study finds
June 23, 2018 - Researchers highlight new nurse training model to address shortage of primary care
June 23, 2018 - New Olympus cellSens 2.1 speeds up image analysis
June 23, 2018 - Attitudes Among Obese Are Not Aligned With Healthy Living
June 23, 2018 - Early birds less prone to depression
June 23, 2018 - Scientists use novel approach to uncover how brain networks interact to make word-choice decisions
June 23, 2018 - Researchers discover shared genetic basis for psychiatric disorders
June 23, 2018 - Study shows fat cells increase in size and number upon exposure to fracking chemicals
June 23, 2018 - Water-limited landscapes can facilitate disease transmission
June 23, 2018 - Exercise May Ease Inflammation Tied to Obesity
June 23, 2018 - Is it their own fault?! How people judge the exclusion of others
June 23, 2018 - Researchers use advanced technology to identify proteomes of Th17 and iTreg cells
June 23, 2018 - Researchers develop low-cost plastic sensors to monitor wide range of health conditions
June 23, 2018 - Lipid-scrambling DNA enzyme outperforms naturally occurring counterpart, say researchers
June 23, 2018 - Apps for children should emphasize parent and child choice, researchers say
June 23, 2018 - Teenage girls report higher degree of daytime sleepiness than boys
June 23, 2018 - Protein Data Bank at Rutgers impacts research, education and drug discovery
June 23, 2018 - Study unravels new piece of information in the Huntington’s disease puzzle
June 23, 2018 - Scientists develop new device to test cancer drug combinations quickly and cheaply
June 23, 2018 - Neural Analytics wins CE Mark for NeuralBot System
June 23, 2018 - Infant omega-3 supplementation tied to decreased waist size
June 23, 2018 - Massive analysis of genomes reveals insights into genetic overlap among psychiatric diseases
June 23, 2018 - New therapeutic approach may delay neurodegeneration in rare genetic disease
June 23, 2018 - Broken shuttle protein may hinder learning in patients with brain disorders
June 23, 2018 - Study finds increase in daily cannabis use among American adults
June 23, 2018 - Researchers create electronic skin that brings back real sense of touch to prosthetic limbs
June 23, 2018 - FIRS: Guidance Offered for Protecting Youth From E-Cigarettes
June 23, 2018 - Scientists unravel molecular mechanisms of Parkinson’s disease
June 23, 2018 - When the Heart Stops, Drugs Often to Blame
June 23, 2018 - Scientists show that a key Parkinson’s biomarker can be identified in the retina
June 23, 2018 - Study finds factors underlying current rise in radicalization among European youth
June 23, 2018 - New study finds higher heart disease risk in bisexual men
June 23, 2018 - Coconut oil diet increases vitality, lifespan of fruit flies with peroxisomal disorder
June 23, 2018 - Jumping genes or transposons and their role in the genetic code
June 23, 2018 - The Current issue of “The view from here” is concerned with Therapeutics
June 23, 2018 - Abnormal lipid metabolism in fat cells predicts future weight gain and diabetes in women
June 23, 2018 - Alcohol problems linked to sex without condom use among black gay men
June 23, 2018 - DNA patterns in circulating blood cells can help identify spastic cerebral palsy
June 23, 2018 - Unsubstantiated health claims widespread within weight loss industry
June 23, 2018 - FDA grants marketing authorization for use of two catheter-based devices in hemodialysis patients
June 23, 2018 - An ingrown toenail not the same as a bypass
June 23, 2018 - Study suggests proteinuria lowering as important target in managing pediatric CKD
June 23, 2018 - Dynamic model helps make predictions about gut microbiome
June 23, 2018 - Research consortium wins £2.9 million to help tackle antibacterial resistance in Thailand
June 23, 2018 - Schizophrenia patients account for over 1 in 10 suicide deaths, study shows
June 23, 2018 - Overdose risk increases five-fold with concurrent opioid and benzodiazepine use
June 23, 2018 - FDA Alert: Kratom (mitragyna speciosa) powder products by Gaia Ethnobotanical: Recall
June 23, 2018 - Study highlights inadequate effort of health care insurers to combat opioid epidemic
June 23, 2018 - CDC chief asks for, and gets, cut to his record $375K pay
June 22, 2018 - Novel cellular pathway may clarify how arterial inflammation develops into atherosclerosis
June 22, 2018 - Pioneering exercise program improves physical, mental health of elderly people living in care homes
June 22, 2018 - Rutgers Cancer Institute educates childhood cancer survivors about late effects of treatment
June 22, 2018 - Study tests accuracy of device designed to detect heart dysfunction in childhood cancer survivors
June 22, 2018 - Study links annual haze with increased hospitalizations for respiratory problems
June 22, 2018 - Robotic surgery appears to be as effective as open surgery in treating bladder cancer
June 22, 2018 - Many Drugs Made Available Via FDA Expanded Access Programs
June 22, 2018 - Normal eye dominance is not necessary for restoring visual acuity in amblyopia
June 22, 2018 - Parent-Child Interaction Therapy can reduce depression rates in children
June 22, 2018 - Study provides insights into how components of different cells in the brain are altered
June 22, 2018 - Research does not confirm antidiabetic action of natural fatty acid derivatives
June 22, 2018 - Oxidative stress can be used against tumors to treat cancer
June 22, 2018 - Simple, cost-effective test may help improve early diagnosis of mild cognitive impairment
June 22, 2018 - New guide published to help battle fatal disease caused by kissing bugs
June 22, 2018 - Stigma Adds to Burden of Type 1 Diabetes
June 22, 2018 - In retinoblastoma survivors, oculo-visual issues tied to QoL
June 22, 2018 - Most adults with allergies do not use prescribed epinephrine even in emergency situations
June 22, 2018 - Study provides clues to how cancer cells develop resistance to chemotherapies
June 22, 2018 - New consensus paper serves as basis for uniform medical management of DSD
June 22, 2018 - Researchers work to identify areas of the brain that help us wake up
June 22, 2018 - Alcohol hangovers more significant and costly than people realize, shows research
June 22, 2018 - Targeting cells involved in blood vessel formation could hinder brain tumor growth
June 22, 2018 - Young cancer survivors need more support as they feel dissatisfied with their sexuality
June 22, 2018 - Unusual cell-to-cell communication in glioblastoma promotes aggressiveness and therapy resistance
Drugmakers blamed for blocking generics have milked prices and cost U.S. billions

Drugmakers blamed for blocking generics have milked prices and cost U.S. billions

image_pdfDownload PDFimage_print

Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found.

As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.

The analysis shows that drug companies that may have engaged in what FDA Commissioner Scott Gottlieb called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.

The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples, and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster cancer drug Revlimid, which accounted for 63 percent of Celgene’s revenue in the first quarter of 2018, according to a company press release.

The brand-name drug companies “wouldn’t put so much effort into fighting off competition if these weren’t [such] lucrative sources of revenue,” said Harvard Medical School instructor Ameet Sarpatwari. “In the case of a blockbuster drug, that can be hundreds of millions of dollars of revenue for the brand-name drugs and almost the same cost to the health care system.”

Indeed, a KHN analysis found that 47 of the drugs cost Medicare and Medicaid almost $12 billion in 2016. The spending totals don’t include rebates, which drugmakers return to the government after paying for the drugs upfront but are not public. The rebates ranged from 9.5 percent to 26.3 percent for Medicare Part D in 2014, the most recent year that data are available.

The remaining drugs do not appear in the Medicare and Medicaid data.

By delaying development of generics, drugmakers can maintain their monopolies and keep prices high. Most of the drugs cost Medicare Part D more in 2016 than they did in 2012, for an average spending increase of about 60 percent more per unit. This excludes drugs that don’t appear in the 2012 Medicare Part D data.

Revlimid cost Medicare Part D $2.7 billion in 2016, trailing only Harvoni, which treats hepatitis C and is not on the FDA’s new list. The cost of Revlimid, which faces no competition from generics, has jumped 40 percent per unit in just four years, the Medicare data show, and cost $75,200 per beneficiary in 2016.

Some drugs on the FDA’s list, including Celgene’s, are part of a safety program that can require restricted distribution of brand-name drugs that have serious risks or addictive qualities. Drugmakers with products in the safety program sometimes say they can’t provide samples unless the generics manufacturer jumps through a series of hoops “that generic companies find hard or impossible to comply with,” Gottlieb said in a statement.

The Department of Health and Human Services Office of Inspector General issued a report in 2013 that said the FDA couldn’t prove that the program actually improved safety, and Sarpatwari said there’s evidence drugmakers are abusing it to stave off competition from generics.

Gottlieb said the FDA will be notifying the Federal Trade Commission about pleas for help from would-be generics manufacturers about obtaining samples, and he encouraged the manufacturers to do the same if they suspect they’re being thwarted by anticompetitive practices.

Celgene spokesman Greg Geissman said the company has sold samples to generics manufacturers and will continue to do so. He stressed maintaining a balance of innovation, generic competition and safety.

“Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst are believed to have similar risks,” Geissman said.

The highest number of pleas for help related to Actelion Pharmaceuticals’ pulmonary hypertension drug Tracleer. In 2016, that drug cost Medicare $90,700 per patient and more than $304 million overall. Meanwhile, spending per unit jumped 52 percent from 2012 through 2016.

Actelion was acquired by Johnson & Johnson’s pharmaceutical arm, Janssen, in 2017.

Actelion spokeswoman Colleen Wilson said that the company “cooperate[s]” with makers of generic drugs and “has responded to all requests it has received directly from generic manufacturers seeking access to its medications for bioequivalence testing.”

PhRMA, the trade group for makers of brand-name pharmaceuticals, said the FDA’s list was somewhat unfair because it lacked context and responses from those it represents.

“While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” said PhRMA spokesman Andrew Powaleny.

Congress is considering the CREATES Act, which stands for “Creating and Restoring Equal Access to Equivalent Samples” and would foster competition in part by allowing generics manufacturers to sue brand-name drug manufacturers to compel them to provide samples.

The bill’s sponsor, Sen. Patrick Leahy (D-Vt.), said more transparency from the FDA is helpful, but more work from the agency is needed to end the anticompetitive tactic. “With billions of dollars at stake, a database alone will not stop this behavior,” Leahy said.

Co-sponsor Sen. Chuck Grassley (R-Iowa), chairman of the Judiciary Committee, expressed similar sentiments, telling KHN: “The CREATES Act is necessary because it would serve as a strong deterrent to pharmaceutical companies that engage in anticompetitive practices to keep low-cost generic drugs off the market.”

The FDA hasn’t come out in support of CREATES. “They should know that this is going to require a legislative solution,” Sarpatwari said. “Why are they not stepping into this arena and saying that?”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation.

Kaiser Health NewsThis article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

Tagged with:

About author

Related Articles