Life Science Compliance Update

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22 posts from February 2018

February 28, 2018

Checking In: Are Your State Legislators Concentrating on Drug-Price Transparency?


Price transparency is such a hot topic today that it is oftentimes hard to keep up with the different state legislatures that are reviewing different ideas on price transparency and price gouging when it comes to the pharmaceutical industry. Below are some of the states and the bills that are pending before the legislatures.


The state of Colorado has two bills pending – one in the House and one in the Senate – that each focus on different aspects of pricing. HB18-1009, the Diabetes Drug Pricing Transparency Act of 2018, has been introduced in the House and assigned to the Health, Insurance, and Environment subcommittee. The bill would require drug manufacturers and pharmacy benefit managers to submit annual reports to the state board regarding drugs used to treat diabetes that are subject to price increases of certain percentages. The state board would have the ability to impose penalties on drug manufacturers or pharmacy benefit managers who do not comply with the reporting requirements. Nonprofit organizations that advocate on behalf of patients with diabetes or funding diabetes medical research that receive contributions from certain diabetes drug manufacturers must annually report those contributions. In the Senate, SB18-152, Prohibit Price Gouging on Prescription Drugs, has been indefinitely postponed by the Senate Committee on State, Veterans & Military Affairs. The bill would have: (1) prohibited a pharmaceutical manufacturer or wholesaler from price gouging on sales of essential off-patent or generic drugs; (2) made the practice of price gouging a deceptive trade practice under the “Colorado Consumer Protection Act;” and (3) required the state board of pharmacy and executive director of the department of health care policy and financing to report suspected price gouging to the attorney general, who is then authorized to seek subpoenas and file lawsuits with the appropriate district courts.


In Hawaii, there is one bill pending that focuses on price transparency, HB2668, “Relating to Prescription Drugs.” The bill would require the Department of Health to compile, analyze, and report certain information on essential prescription drugs marketed in Hawaii for the treatment of diabetes. It would also require certain entities to provide information that justifies the cost increases in drug products. The bill has been referred to HHS, CPC, and FIN for further deliberations.  


In Illinois, HB4900, has been introduced and is currently in the Human Services Committee. The legislation creates the Illinois Generic Drug Pricing Fairness Act, which would provide in part that manufacturers and wholesale drug distributors shall not engage in price gouging in the sale of an essential off-patent or generic drug. It would also allow the Director of Healthcare and Family Services or Director of Central Management Services to notify the Attorney General of any increase in the price of any essential off-patent or generic drug under the Medical Assistance Program under the Illinois Public Aid Code or a State health plan that amounts to price gouging.


The Maine Legislature has introduced bills LD1406 and SP 484, An Act to Promote Prescription Drug Price Transparency, in each of its chambers. The bills are currently in committee.


The state of Maryland has three separate bills in motion right now that all deal with price transparency. The first bill, HB1194, Health – Drug Cost Review Commission, would establish the Drug Cost Review Commission; provide for the purpose and the membership of the Commission; provide for the election of the chair of the Commission and requiring the chair to hire certain staff; and requiring that the staff of the Commission receive a certain salary. This bill is cross-filed with SB1023, a Senate bill with the same ideal outcome.

SB0201, Public Health – Prescription Drug Manufacturers – Sales to Wholesale Distributors, would require a prescription drug or device manufacturer to submit certain average sales prices to the Maryland Department of Health for each calendar quarter within 30 days after the end of the quarter and require the Department to make the average sales price submitted by a manufacturer available on the Department's website not later than 10 days after it receives the average sales prices.


In Michigan, the Senate has introduced SB0825, Health; pharmaceuticals; annual report on the costs associated with prescription drugs; require manufacturers of prescription drugs to file in certain circumstances. Amends 1978 PA 368 (MCL 333.1101 - 333.25211) by adding secs. 17748e & 17748f. The bill would require an annual report on the costs associated with prescription drugs and would require manufacturers of prescription drugs to file in certain circumstances.


Mississippi legislators tried and failed to pass two bills relating to price transparency. HB 137, Prohibition on Price Gouging for Essential Drugs Act, would have created such an act and defined price gouging and then prohibited manufacturers and wholesale distributors from engaging in price gouging. HB 784, Prescription drugs; require Attorney General to compile certain lists of those essential for treating diabetes and costs of, would have required the Attorney General to compile certain lists of prescription drugs that are essential for treating diabetes and the wholesale acquisition cost of each such drug on the list and those drugs on the list that have been subject to an increase in WAC by a certain percentage during the preceding calendar year or years.


In Nebraska, legislators are currently considering LB862, Adopt the Prescription Drug Cost Transparency Act.  This bill would require notice and disclose of the information relating to the cost and pricing of prescription drugs in order to provide accountability to the state for prescription drug pricing; allow a manufacturer of a prescription drug to voluntarily make pricing decisions regarding the prescription drug, including any price increases; and permit both public and private purchasers of prescription drugs to negotiate discounts and rebates for prescription drugs consistent with state and federal law.

New Hampshire

In New Hampshire, legislators are currently looking at HB1418, Relative to Transparency and Cost Control of Pharmaceutical Drug Prices. This bill would require the commissioner of the department of health and human services, in consultation with the insurance commissioner, to develop a list of certain critical prescription drugs for purposes of cost control and transparency.  Under this bill, the commissioner shall make an annual report on prescription drugs and their role in overall health care spending in the New Hampshire.

New Jersey

In New Jersey, there are currently three bills pending before the legislature. A583, introduced in the Assembly, and S983, introduced in the Senate, would establish the Prescription Drug Review Commission and require that production costs be reported for certain prescription drugs. S1590, introduced in the Senate, would prohibit excessive increases in prices that are charged for essential off-patent and generic prescription drugs and biological products.

New York

In New York, there are three bills pending before the two houses of the legislature. S02544 (in the Senate) and A05733 (in the Assembly), are entitled, “Prohibits price gouging by manufacturers of prescription drugs.” These bills would amend the public health law and general business law, in relation to price gouging on prescription drugs. Also introduced in the Assembly is A02939, Relates to prescription drug cost transparency. This bill would make information available to the public about the cost and utilization of pharmaceutical drugs. To fulfill this goal, the legislature finds that there should be annual reporting of drug costs and use that would be of use by policymakers, government agencies and others to understand pharmacy cost trends.


In Oregon, HB 4005 A, Relating to the price of prescription drugs, would require prescription drug manufacturers to report annually information to Department of Consumer and Business Services regarding prices of prescription drugs and costs associated with developing and marketing prescription drugs.

Rhode Island

In Rhode Island, there are two bills pending with the House. H7004, would direct the state board of pharmacy, in collaboration with the department of health, to annually identify up to fifteen (15) prescription drugs on which the state spends significant health care dollars due to increases in costs. This list would be provided to the attorney general's office, and the attorney general‘s office would require the drug's manufacturers to submit relevant information and documentation to justify these cost increases. The act would also direct the department of health to use the same dispensing fee in its reimbursement formula for 340B prescription drugs as it uses to pay for non-340B prescription drugs under the Medicaid, program, and to provide information to the general assembly and the governor about these programs. The act would also establish an advisory commission on out-of-pocket prescription drug costs who would study these costs and make reports and recommendations to the governor and the general assembly.

H7042, on the other hand, would direct the state board of pharmacy, in collaboration with the Rhode Island department of health, to annually develop a list of critical prescription drugs for which there is a substantial public interest in understanding the development of the drugs' price. The act would also authorize the board to obtain certain information from manufacturers of the critical prescription drugs. The act would also allow the commission to set the maximum allowable price that a manufacturer can charge for a prescription drug if the commission determines that the cost of a prescription drug is significantly high.

Both bills are currently in committee.

South Carolina

In South Carolina, H4490 has been introduced, which would require manufacturers of diabetes prescription drugs to provide certain cost information to the department of health and environmental control, and for the department of health and environmental control to post the reported information on its publicly accessible website.


In Utah, HB0163 has been introduced, which would create a program and reporting requirements relating to prescription drugs and the importation of prescription drugs, including specific instructions for the Department of Health and drug manufacturers.


In Virginia, HB 1436, “Prescription drugs; price transparency,” has been introduced and is in Committee. The bill requires every manufacturer of a prescription drug that is made available in the Commonwealth and has a wholesale acquisition price of $10,000 or more for a single course of treatment to report to the State Health Commissioner no later than July 1 of each year information related to the cost of developing, manufacturing, and marketing the prescription drug; any changes in the average wholesale price and average wholesale acquisition cost of the prescription drug; the amount of profits derived from sale of the prescription drug; and the total amount of financial assistance provided to consumers of the prescription drug. The bill adds this reported data to the list of reports that the Commissioner causes to be published on a website maintained by a nonprofit entity with which the Commissioner has entered into a contract for such purpose and requires the Commissioner to annually report on such information, in aggregate form, to the Chairmen of the House Committees on Appropriations and on Health, Welfare and Institutions and the Senate Committees on Finance and on Education and Health.


In Vermont, there are two bills relating to price transparency and gouging pending. H713, An act relating to prohibiting price gouging for essential off-patent or generic drugs, which proposes to prohibit prescription drug manufacturers and wholesale distributors from engaging in price gouging in the sale of essential off-patent or generic drugs. S175, An act relating to the wholesale importation of prescription drugs into Vermont, bulk purchasing, and the impact of prescription drug costs on health insurance premiums, proposes to establish a program to allow wholesale importation of prescription drugs from Canada into Vermont. It would create a bulk purchasing program for prescription drugs through the Department of Health and require prescription drug manufacturers to provide notice before introducing new, high-cost drugs to the market. The bill would also require health insurers to provide information about the impact of prescription drug spending on premium rates as part of the Green Mountain Care Board’s rate review process and direct the Board to publish an annual report demonstrating the overall impact of drug costs on health insurance premiums.


In Washington, there are seven bills pending (three bills with components in the House and Senate, with one extra bill in the Senate). SB5401 and HB1541 both entitled, “Addressing prescription drug cost transparency,” would: (1) require the office of financial management to use a competitive procurement process to select a data organization to collect, verify, and summarize the prescription drug pricing data provided by issuers and manufacturers; (2) require an issuer to submit certain prescription drug cost and utilization data to the data organization for the previous calendar year; (3) require a covered manufacturer to report certain data for each covered drug to the data organization; and (4) require the data organization to compile the data submitted by issuers and manufacturers, prepare an annual report for the public and the legislature summarizing the data, and provide the report to the office of financial management and the joint select committee on health care oversight.

HB 2299 and SB 6032, “Making supplemental operating appropriations,” both make 2018 supplemental operating appropriations.

HB2556 and SB5995, “Protecting consumers and purchasers from excessive increases in generic prescription drug prices,” would both require the state institute for public policy to: (1) Review and study policy recommendations for protecting consumers against excessive prescription drug price increases, including a two-year look back of increases where the wholesale acquisition cost increased by a percentage equal to or greater than one hundred percent at any one time or in the aggregate in any twelve-month period; and (2) Report the findings to the legislature.

SB 5586-S2 would provide notice and disclosure of information regarding the cost and pricing of prescription drugs to provide accountability to the state for prescription drug pricing.

February 27, 2018

Watson Pharmaceuticals – Now Part of Teva – to Pay $33 Million to Mississippi


On January 29, 2018, Mississippi Attorney General Jim Hood announced a $33 million settlement with pharmaceutical manufacturer, Watson, Inc., which is now part of Teva Pharmaceuticals.

AG Hood had hired attorneys to sue Watson in a series of suits claiming the company wrongly inflated prescription drug prices paid by the state-federal Medicaid health insurance program.

The State’s Supreme Court upheld a trial court decision that found Watson defrauded the taxpayers of Mississippi by an estimated $7 million when reporting its Average Wholesale Prices. Inflated prices varied from drug to drug, in some cases as much as 1,000 percent. As a result of this fraud, the trial court awarded the state statutory and punitive damages for a total of $33,408,546.72. The Watson case was one of dozens brought against other drug companies that also inflated drug prices causing Mississippi Medicaid to pay too much for prescription drugs.

According to AG Hood, “Of all the companies we have done battle with, Watson Pharmaceuticals is one of the worst offenders. The trial court found they overcharged the state by 1,000 percent on some drugs. A chancery judge in Rankin County issued a $20 million punitive damage verdict, which was upheld by the Mississippi Supreme Court. These types of corporate robbers get away with it unless an attorney general holds them accountable.”

Hood is now using this settlement to disparage current legislative proposals that would limit his power to sue. Mississippi House Bill 1238, recently passed by the House, would bar him from suing under the state’s consumer protection law if the practices are permitted by other Mississippi or federal regulators.

In his press release announcing the settlement, AG Hood also released a statement,

“Should HB 1238 pass, it would be devastating to the protection of Mississippians,” said General Hood. “Much of the successes in our office have been protecting consumers from corporate wrongdoers, and the people of Mississippi deserve more than their lawmakers stripping those protections.”

According to local reports, it is unclear whether the measure will survive in the Senate.

The total settlement is $33,408,546.72, of which $8,143,572.49 are compensatory damages to the Medicaid unit of Mississippi, $5,241,000.00 are civil penalties, and $20,023,974.23 are punitive damages.  

February 26, 2018

E&C House Subcommittee Slated to Review Eight Bills on Opioids


Recently, the House Energy & Commerce Health Subcommittee announced that it will hold a hearing on Wednesday, February 28, 2018, at 10:00 am, to review eight bills that will attempt to curtail the opioid epidemic. The hearing, “Combating the Opioid Crisis: Helping Communities Balance Enforcement and Patient Safety,” is the first of three planned legislative hearings to examine the opioid crisis and possible legislative solutions.

The following bills are expected to be considered during that hearing:

  • H.R. 2851, the Stop the Importation and Trafficking of Synthetic Analogues (SITSA) Act, introduced by Representative John Katko, would provide law enforcement the tools that they need to get elicit synthetic drugs (i.e., fentanyl) off the streets without compromising important public health and research protections. The bill will also modernize scheduling guidelines and make the guidelines more efficient to keep pace with the fast-changing nature of synthetic drugs.
  • H.R. 5041, the Safe Disposal of Unused Medication Act, is a bipartisan piece of legislation authored by Representatives Tim Walberg and Debbie Dingell that will reduce the number of unused controlled substances that are at risk of diversion or misuse by permitting hospice workers to safely dispose of those medications in patients’ homes.
  • H.R. __, the Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018, is a current discussion draft written by Representative Ryan Costello and Rick Nolan, that would make long overdue updates to federal law to improve dispensing of implantable and injectable therapies – developed to make abuse, misuse, and diversion more difficult.
  • H.R. __, the Special Registration for Telemedicine Clarification Act of 2018, a discussion draft written by Representatives Buddy Carter and Cheri Bustos will clarify telemedicine waivers. Federal law permits the Attorney General to issue a special registration to health care providers to prescribe controlled substances via telemedicine in legitimate emergency situations, such as a lack of access to an in-person specialist. Unfortunately, the waiver process has never been implemented through regulation, and some patients do not have the emergency access they need to treatment. This bipartisan draft directs the Attorney General, with the Secretary of Health and Human Services, to promulgate interim final regulations within 30 days of passage of the law.
  • H.R. __, the Improving Access to Remote Behavioral Health Treatment Act of 2018, a bipartisan discussion draft written by Representatives Gregg Harper and Doris Matsui will expand access for patients in rural and underserved communities who may live near community mental health or addiction treatment centers, but not a hospital or state-licensed clinic. Without a DEA registration these health facilities do not qualify for the Ryan Haight Act’s telemedicine exception and are unable to provide care to patients in need. This proposal would direct the Attorney General, with the Secretary of Health and Human Services, to promulgate interim final regulations within 120 days of passage of the law for these treatment facilities to register with the DEA to engage in the practice of telemedicine.
  • H.R. __, the Tableting and Encapsulating Machine Regulation Act of 2018, written by Representative David Kustoff, this discussion draft seeks to crack down on synthetic drug trafficking by giving the DEA authority to regulate the use of tableting and encapsulating machines with requirements for: (1) the maintenance of records; (2) inspections for verifying location and stated use; and (3) security provisions.
  • H.R. 2063, the Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017, authored by Representative Brad Schneider, aims to improve provider understanding of pain management treatment guidelines and best practices, early detection of opioid addiction, and the treatment and management of opioid-dependent patients by requiring 12 hours of continuing medical education on the topic every three years.
  • H.R. 4275, Empowering Pharmacists in the Fight Against Opioid Abuse Act, sponsored by Representatives Mark DeSaulnier and Buddy Carter, this bill seeks to help pharmacists detect fraudulent prescriptions. The bill would require the DEA to develop training programs and materials on the circumstances under which a pharmacist may refuse to fill a controlled substance prescription suspected to be fraudulent, forged, or indicative of abuse or diversion.

“As we continue our efforts to tackle this epidemic, it’s imperative we strike the right balance between necessary enforcement and patient safety,” said Michael C. Burgess, Chairman of the Subcommittee on Health. “As the people’s representatives, we need to make sure law enforcement can get dangerous, illicit drugs out of our communities and licensed health professionals are able to safely dispose of unused prescriptions, particularly opioids. We’ll examine a number of important policies that will improve access to treatment for mental health and substance use disorders, make important updates to outdated laws, review ideas on how providers and pharmacists can better inform patients, all with the common goal of protecting our family, friends, and neighbors.”



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