Posts Tagged FDA

President Trump Signs Right-to-Try Act

President Trump Signs Right-to-Try Act

On Wednesday, May 30, 2018, Pres. Donald Trump signed the Right-to-Try Act, which allows terminally ill patients the ability to try drugs in preliminary testing but not-yet-approved by the Food and Drug Administration. The aim is to make it easier for those patients suffering from fatal illness who have exhausted all other resources to access drugs unapproved by the FDA, which may provide them some relief from their illnesses.

The Right-to-Try Act is also intended to create a more open and competitive market for drugs still seeking FDA approval, therefore, lowering the cost of the drugs since insurance companies do not cover them. Supporters of the legislation say it gives hope to those who are out of options, while opponents argue the legislation gives a false hope to many who are already in a vulnerable and fragile state.

While the intent is to allow patients to try drugs not otherwise available to them, many point out the FDA already allows patients access to these drugs through an expanded access program. This program allows terminally ill patients access to drugs not FDA approved, ensures the drug is administered correctly and certifies those receiving the medication are adequately informed. Additionally, the approval rate of patients completing the application requesting these drugs since 2006 is 99 percent.

Supporters of the Right-to-Try Act argue these numbers do not reflect the hundreds of patients neglected by the application process through incomplete applications and other factors. Now, the Right-to-Try Act takes the FDA out of the equation and leaves the power with patients and their physicians to work with drug companies directly to access unapproved drugs.

Despite its potential for success, the Right-to-Try Act comes with a significant downside. Since the only requirement for the drugs are that they have passed Phase I testing with the FDA stating they are safe on humans, there is no real understanding of possible side effects these drugs may have on patients. The uncertainty and margin of error around medications not approved by the FDA leave physicians concerned for the health and safety of the patients who choose to use them.

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Trump Administration Releases Drug Pricing Blueprint

Trump Administration Releases Drug Pricing Blueprint

On May 11, The Trump Administration released “American Patients First,” the President’s blueprint to lower drug prices and reduce out-of-pocket costs, along with a request for information. The Blueprint was framed as advancing four specific goals:

  • Reducing list prices;
  • Improving government’s ability to negotiate better prices;
  • Encouraging competition through rapid entry to market of generics and biosimilars; and
  • Lowering patient out-of-pocket expenses.

The Blueprint proposes a broad number of changes to prescription drug programs in several federal health care programs – such as Medicare, Medicaid and other safety net programs – as well as Food and Drug Administration policies that should impact commercial and federal health care program access to affordable prescription drugs.

While some of these proposals can be undertaken through immediate regulatory or subregulatory actions, others are still on the drawing boards at the U.S. Department of Health and Human Services and some will require congressional action to implement. The Blueprint proposes a select number of programmatic and design changes, yet the Administration is seeking feedback for a large number of lingering questions.

Initial review appears to show an increased access to lower-cost alternative generics. But closer review is needed on proposed changes to the Medicare Part D Prescription Drug Benefit Program and the Part B drug reimbursement methods to alleviate concerns the changes may limit patient access to medically necessary alternative brand or specialty treatments and result in additional administrative burdens on physicians and patients. The proposal may also eliminate the requirement that Part D plans include a minimum of two drugs proven to be effective in each therapeutic category or pharmacologic class, if available.

The Medical Association will be closely monitoring the Administration’s “American Patients First” Blueprint and will keep our members updated on any new developments as they become available.

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FDA Classifies Kratom as Opioid

FDA Classifies Kratom as Opioid

The U.S. Food and Drug Administration has officially classified the plant kratom, originally seen as an opioid alternative, as an opioid itself, stating that compounds in kratom act like prescription-strength opioids.

Found in Malaysia, the leaves of the kratom plant are traditionally crushed and made into a tea to treat pain as well as heroin or morphine dependence and possibly reduce withdrawal cravings. According to the American Kratom Association, there are 3 million to 5 million kratom users in the U.S. The supplement can be found in head shops and gas stations sold as powders, pills, capsules and energy drinks.

FDA scientists analyzed the chemical structures of the 25 most common compounds in kratom and concluded that all of the compounds share structural characteristics with controlled opioid compounds, such as morphine derivatives. They also found that compounds in kratom bind strongly to mu-opioid receptors, comparable to opioid drugs.

The scientific data and event reports have “clearly revealed” compounds in kratom make it “not just a plant — it’s an opioid,” said FDA Commissioner Scott Gottlieb, M.D., “and it’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold, and used recreationally and by those who are seeking to self-medicate for pain or who use kratom to treat opioid withdrawal symptoms.”

The FDA announced the voluntary destruction and recall of all kratom-based products manufactured nationwide under the brand names Botany Bay, Enhance Your Life and Divinity by Divinity Products Distribution. The FDA encourages all companies currently involved in the sale of products containing kratom intended for human consumption to take their products off the market and submit any necessary evidence to the FDA.

“The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death,” said Dr. Gottlieb. “To protect the public health, we’ll continue to affirm the risks associated with kratom, warn consumers against its use and take aggressive enforcement action against kratom-containing products.”

The FDA recommends consumers not use any kratom products and dispose of any products currently in their possession. “At this time, there’s no evidence to indicate that kratom is safe or effective for any medical use,” said Dr. Gottlieb.

The FDA has received 44 reports of deaths associated with the use of kratom. Additionally, the FDA and the U.S. Centers for Disease Control and Prevention are carefully monitoring an active nationwide outbreak across 20 states of a rare type of salmonella associated with kratom products.

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What If No One Was on Call [at the Legislature]?

What If No One Was on Call [at the Legislature]?

2017 Legislative Recap

In times of illness, injury and emergency, patients depend on their physicians. But what if no one was on call? Public health would be in jeopardy. However, the same holds true during a legislative session. What would happen if the Medical Association was not on call, advocating for you and your patients at the legislature? Keep reading to find out.

Moving Medicine Forward

Continued success in the legislative arena takes constant vigilance. Click here to see our 2017 Legislative Agenda.

If no one was on call… Alabama wouldn’t be the 20th state to enact Direct Primary Care legislation. DPC puts patients and their doctors back in control of patients’ health and helps the uninsured, the underinsured and those with high-deductible health plans. SB 94 was sponsored by Sen. Arthur Orr (R-Decatur) and Rep. Nathaniel Ledbetter (R-Rainsville) and awaits the Governor’s signature.

If no one was on call… the Board of Medical Scholarship Awards could have seen its funding slashed but instead, the program retained its funding level of $1.4 million for 2018. The BMSA grants medical school loans to medical students and accepts as payment for the loan that student’s locating to a rural area to practice medicine. The BMSA is a critical tool for recruiting medical students to commit to practice in rural areas. As well, the economic footprint of every physician is at least $1 million, which improves both community health and local economies.

If no one was on call… Medicaid cuts could have been severe, possibly reducing access for patients within an already fragile system in which less than 20 percent of Alabama physicians participate. Due to work done during the 2016 second special session and the 2017 session, sufficient funds were made available for Medicaid without any scheduled cuts to physicians for 2018. Increasing Medicaid reimbursements to Medicare levels — a continuing priority of the Medical Association — could further increase access to care for Medicaid patients.

Beating Back the Lawsuit Industry

Personal injury lawyers are constantly seeking new opportunities to sue doctors. While Alabama’s medical liability laws have fostered fairness in the courtroom and improved the legal climate, each year personal injury attorneys seek to undo parts of the very law that helps keep “jackpot justice” and frivolous suits in check.

If no one was on call… an $80 million tax increase on physicians to fund a new government-administered malpractice claims payout system called the Patients Compensation System could have passed. The PCS would administer damage claims for physical injury and death of patients allegedly sustained at the hands of physicians. Complaints against individual physicians would begin with a call to a state-run 1-800 line and would go before panels composed of trial lawyers, citizens and physicians to determine an outcome. In addition, any determinations of fault would be reported to the National Practitioner Databank. The Patient Compensation System would undo decades of medical tort reforms which the Medical Association championed and is forced to defend from plaintiff lawyer attacks each session. The PCS deprives both patients and doctors of their legal rights.

If no one was on call… physicians could have been exposed to triple-damage lawsuits for honest Medicaid billing mistakes. The legislation would create new causes of civil action in state court for Medicaid “false claims.” The legislation would incentivize personal injury lawyers to seek out “whistleblowers” in medical clinics, hospitals and the like to pursue civil actions against physicians and others for alleged Medicaid fraud, with damages being tripled the actual loss to Medicaid. The standard in the bill would have allowed even honest billing mistakes to qualify as “Medicaid fraud,” creating new opportunities for lawsuits where honest mistakes could be penalized.

If no one was on call… physicians would have been held liable for the actions or inactions of midwives attending home births. While a lay midwife bill did pass this session establishing a State Board of Midwifery, the bill contains liability protections for physicians and also prohibitions on non-nurse midwives’ scope of practice, the types of pregnancies they may attend and a requirement for midwives to report outcomes.

If no one was on call… the right to trial by jury, including jury selection and jury size, could have been manipulated in personal injury lawyers’ favor.

If no one was on call… physicians could have been held legally responsible for others’ mistakes, including home caregivers, medical device manufacturers and for individuals following or failing to follow DNR orders.

Protecting Public Health and Access to Quality Care

Every session, various pieces of legislation aimed at improving the health of Alabamians are proposed. At the same time however, many bills are also introduced that endanger public health and safety, like those where the legislature attempts to set standards for medical care, which force physicians and their staffs to adhere to non-medically established criteria, wasting health care dollars, wasting patients’ and physicians’ time and exposing physicians to new liability concerns.

If no one was on call… legislation could have passed to lower biologic pharmaceutical standards in state law below those set by the FDA, withhold critical health information from patients and their doctors and significantly increase administrative burdens on physicians. ICYMI, read our joint letter to the Alabama Legislature opposing the bill.

If no one was on call… allergists and other physicians who compound medications within their offices could have been shut down, limiting access to critical care for patients.

If no one was on call… numerous scope of practice expansions that endanger public health could have become law, including removing all physician oversight of clinical nurse specialists; lay midwives seeking allowance of their attending home births without restriction or regulation; podiatrists seeking to amputate, do surgery and administer anesthesia up the distal third of the tibia; and marriage and family therapists seeking to be allowed to diagnose and treat mental disorders as well as removing the prohibition on their prescribing drugs.

If no one was on call… state boards and agencies with no authority over medicine could have been allowed to increase medical practice costs through additional licensing and reporting requirements.

If no one was on call… legislation dictating medical standards and guidelines for treatment of pregnant women, the elderly and terminal patients could have been placed into bills covering various topics.

Other Bills of Interest

Rural physician tax credits… legislation to increase rural physician tax credits and thereby increase access to care for rural Alabamians did not pass but will be reintroduced next session.

Infectious Disease Elimination… legislation to establish infectious disease elimination pilot programs to mitigate the spread of certain diseases failed to garner support on the last legislative day.

Constitutional amendment proclaiming the State of Alabama’s stance on the rights of unborn children… legislation passed to allow the people of Alabama to vote at the November 2018 General Election whether to add an amendment to the state constitution to:

“Declare and affirm that it is the public policy of this state to recognize and support the sanctity of unborn life and the rights of unborn children, most importantly the right to life in all manners and measures appropriate and lawful…”

If ratified by the people in November 2018, this Amendment could have implications for women’s health physicians.

Coverage of autism spectrum disorder therapies… legislation passed to require health plans to cover ASD therapies, with some restrictions.

Portable DNR for minors… legislation establishing a portable DNR for minors to allow minors with terminal diseases to attend school activities failed to garner enough votes to pass on the last legislative day.

If the Medical Association was not on call at the Alabama Legislature, countless bills expanding doctors’ liability, increasing physician taxes, and setting standards of care into law could have passed. At the same time, positive strides in public health — like passage of the direct primary care legislation — would not have occurred. The Medical Association is Alabama physicians’ greatest resource in advocating for the practice of medicine and the patients they serve.

Click here for a downloadable version of our 2017 Legislative Recap.

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Official Statement on Legalization of Non-FDA Approved Marijuana Substances

Official Statement on Legalization of Non-FDA Approved Marijuana Substances

March 18, 2016 – “The use of marijuana for the treatment of various symptoms of diseases is an evolving discussion in this state and nation. Two years ago, the Alabama Legislature wisely decided and the Medical Association supported putting the discussion surrounding the efficacy of cannabidiol (CBD) in the treatment of neurologic conditions in children to the test by establishing and funding a strictly controlled drug trial. The preliminary results of that study indicate promise for more widespread use of CBD in patients. The exact CBD drug itself and dosages administered to patients in this drug trial were strictly regulated to ensure the safety of those involved. As physicians, our Hippocratic Oath demands we ‘first, do no harm.’ As well, the practice of medicine is evidence-based whereby the treatments and procedures we use are extensively researched and tested to make certain they are as safe as possible for the patients under our care. Given these bedrocks of the medical profession, the Medical Association cannot support the expansion or legalization, whether by legislation or ballot initiative, of marijuana or marijuana products in any form that have not received the same FDA approval as other medicinal compounds. Taking any position otherwise would not be based on scientific evidence and could unnecessarily place patients at risk.”

– Buddy Smith, M.D., president, Medical Association of the State of Alabama

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