Category Archives: Drug Companies

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California Governor Signs Flurry Of Health Laws

Gov. Jerry Brown signed off on a variety of bills in September that aim to protect patients and health care consumers.

The following laws are set to go into effect in 2017.

AB 72: “Surprise medical bill” legislation by Assemblyman Rob Bonta (D-Oakland) was among the most-talked-about measures of the year in Sacramento. It promises to better protect consumers against unexpected medical bills.

Patients can receive such bills when they use a hospital or clinic considered in-network by their insurance plan but are treated by a provider who does not contract with the insurer such as radiologists, anesthesiologists and pathologists. With the goal of keeping patients out of the fight between providers and insurers, the new law essentially sets a reimbursement rate requiring insurers to pay out-of-network doctors 125 percent of the amount Medicare pays for the service or the insurer’s average contracted rate, whichever is greater.

“With his signature, Governor Brown has enacted some of the strongest patient protections in the nation against surprise medical bills. This issue has been debated but has gone unresolved for decades,” Bonta said in a statement.

SB 482: Amid a national opioid epidemic, Brown approved legislation that requires doctors to check a patient’s prescription history in a state database before prescribing any potentially addictive drugs.

The bill, by Sen. Ricardo Lara (D-Bell Gardens), calls for doctors to consult California’s prescription drug monitoring database when prescribing controlled substances. Failure to do so under the new law could result in disciplinary action, although there is no way to ensure that doctors actually use this tool before prescribing.

The new law is meant to put a stop to “doctor shopping” — the practice of visiting multiple doctors to obtain prescription for opioids.

SB 586: The legislation, a compromise between the Department of Health Care Services and children’s advocates, aims to slow down and improve plans to overhaul the way the state’s most medically fragile children receive care.

Currently, severely ill children with conditions like cancer or cerebral palsy receive care through an 89-year-old state program known as California Children’s Services. The Department of Health Care Services announced its plan last year to move these children into Medi-Cal managed care plans to streamline their care. Parents and child advocates argued that the transition was too quick and poorly planned, and could interrupt care for these children. The bill adds changes demanded by parents and advocates to improve case management and coordination for children affected by the transition.

The bill, introduced by the head of the state’s Senate Health Committee, Sen. Ed Hernandez (D-West Covina), allows DHCS to implement the transition to 21 counties by July 2017. The remaining counties will follow. The full transition of the state’s 190,000 children should be complete by 2022.

Ann-Louise Kuhns, president and CEO of the California Children’s Hospital Association, said the new law “both protects the high quality of care assured by the California Children’s Service program and promotes a careful, phased integration with managed care.”

SB 908: This bill will allow consumers to learn when their health insurance premium rates have been considered “unreasonable” by state officials. Current law requires that unreasonable rate hikes be posted online by one of the two state agencies that regulate insurers — the Department of Managed Health Care or the California Department of Insurance. But consumers don’t check online, the bill’s supporters argued.

The new law will require insurers to notify individuals and small businesses directly in writing — at least 60 days before the rate changes — so that consumers can shop around if they choose.

“This law will discourage unjustified health plan rate hikes and empower consumers to make informed decisions about the coverage they are choosing,” said Anthony Wright, executive director of Health Access California, a Sacramento-based consumer advocacy group.

SB 1076: This law, sponsored by the California Nurses Association, was designed to protect hospital patients in “observation” care. It requires that observation units meet the same staffing standards — nurse-to-patient ratios — as those in the emergency room.

Outpatient services are not covered by the same patient protection regulations as inpatient units, and many times patients are left in an observations status for a long period of time, according to supporters of the law. In addition, such treatment is not counted toward the three days of hospitalization that Medicare requires for a patient to be covered for nursing home care once they are discharged from the hospital.

The new law will also require that hospitals report summaries of the care they provide during observation status to the Office of Statewide Health Planning and Development for data collection.

Sourced From  – http://californiahealthline.org/news/california-governor-signs-flurry-of-health-laws/

Celebrity Mad Dash to Supply Legal Grass

Sanofi Files Suit Against Merck, Claiming Patent Infringements

French drugs firm takes legal steps to prevent the launch of rival versions of its diabetes treatment

A packet of diabetes drug Lantus SoloStar on the production line at a manufacturing site of French drugmaker Sanofi in Frankfurt, Germany. The French company has filed a lawsuit against U.S. peer Merck & Co. to prevent it from launching a rival version of its diabetes treatment. PHOTO: REUTERS

PARIS— Sanofi SA said it filed a lawsuit against Merck & Co. for alleged patent infringements to prevent the U.S. drugmaker from launching a rival version of the French pharmaceutical giant’s best-selling diabetes treatment Lantus.

In the filing in the U.S. District Court of Delaware, Sanofi said on Monday it claims that Merck Sharp & Dohme Corp., Merck & Co.’s international division, violated as many as 10 patents held by the French company, including ones for its insulin Lantus and its insulin delivery device soloSTAR.

The Paris-based drugs company said it started the legal proceedings against Merck after the U.S. firm’s filing for new drugs applications with the U.S. Food & Drug Administration.

A spokeswoman for Merck said the company’s product “doesn’t infringe Sanofi’s patents.”

Sanofi shares were 1.3% higher at €69.91 in midday trading.

The French drugmaker’s all-important diabetes business is under siege, as a flurry of pharmaceutical companies seek to sell knockoffs of its blockbuster insulin Lantus in the U.S. The expected launch of lower-cost copies of Lantus and growing pricing pressure on diabetes drugs in the U.S. is rapidly eroding earnings at Sanofi’s diabetes division, which accounts for about 20% of the firm’s total revenue.

In the first six months of the year, diabetes revenue fell by 6% to €2.9 billion ($3.2 billion), hit by a 15% drop in Lantus sales to €2.38 billion. The company has said it expects revenue from diabetes drugs to continue to decline this as competition among insulin makers intensifies.

In January 2014, Sanofi filed a suit against Eli Lilly & Co. to defend its patents on Lantus. It had reached a deal with the U.S. drugmaker nearly two years later, under which Lilly agreed to delay the launch of its insulin to December 2016 and pay royalties to Sanofi.

In a bid to replenish its new drugs pipeline and revive growth, Sanofifor months had pursued U.S. biotech Medivation—a Nasdaq-listed company that focuses on hard-to-treat cancers, markets one prostate-cancer therapy, Xtandi, and has two other oncology assets in clinical development.

But U.S. pharma giant Pfizer Inc. beat out Sanofi grabbing Medivation for $14 billion in August.

Sourced From  – http://www.wsj.com/articles/sanofi-files-suit-against-merck-on-patent-infringements-1474285467

Arizona Drug Firm Insys Makes Synthetic Pot Compound, Spends Big to Defeat Legal Pot

THURSDAY, SEPTEMBER 8, 2016 AT 2:53 P.M.
A Chandler-based drug firm under investigation for its aggressive sales of a lethal painkiller claims that the large donation it made to a group that opposes marijuana legalization was an attempt to protect the public’s safety.
A Chandler-based drug firm under investigation for its aggressive sales of a lethal painkiller claims that the large donation it made to a group that opposes marijuana legalization was an attempt to protect the public’s safety.
A Chandler-based drug firm under investigation for its aggressive sales of a lethal painkiller claims that the large donation it made to a group that opposes marijuana legalization was an attempt to protect the public’s safety.
Prop 205 “fails to protect the safety of Arizona’s citizens, and particularly its children,” according to a statement Insys provided to New Times on Thursday in response to a message left for CEO John Kapoor. “Our stance is consistent with our company’s goals. We strive to develop pharmaceutical products for the supportive care of patients while taking patient safety very seriously. To that end, we believe that all available medicines should meet the clinical standards set by the FDA.”
Yet while Insys holds itself out as the savior of Arizonans’ health, the company is reportedly under investigation in four states, including Arizona, for marketing practices related to Subsys that have allegedly resulted in patient deaths.