Life Science Compliance Update

April 20, 2017

FDA Under Pressure to Speed Up Generic Approvals

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As has been reported, the FDA is under pressure to speed up approval of generic medicines. In response, the FDA released data indicating its actions on the approval of generic medication. However, as noted by NPR in one example consumers and lawmakers pushing for cheaper alternatives to the EpiPen and other high-priced medications are seeking answers about what they describe as a “stubborn” backlog.

FDA’s response

In Kathleen Uhl, MD’s presentation (Director, Office of Generic Drugs at CDER within FDA), she stated the agency is meeting all of its obligation under GDUFA and even going above and beyond its commitments. FDA states it is “building a modern, 21st Century generic drug program,” which is resulting in “significant and sustained increases in communications, actions & approvals.”

According to numbers from FY2016, FDA approved 190 generic drugs with tentative approval to 48. December 2016 was the highest number of approvals and tentative approvals in one month ever for the FDA at 99. CY2015 broke the record for the highest number ever in a year at over 700+.

To continue building the FDA’s operations, Uhl stressed an interested in foundational restructuring, the building of more internal FDA infrastructure, improvement of business processes, hiring and training more staff, a new IT platform, and improved communications. Regarding IT improvements, FDA says it improved communication and increased productivity—a direct result of its improved IT system for the generic drug program. This provides the agency with workload management and review management tools. They have assigned over 130,000 items in this new platform.

The presentation offers a lot of data which is worth reviewing. However, it also stresses there is “no filing backlog” and that filing is currently done in “real time” (31 days). The first step in review is filing. Something acceptable for filing means the application is sufficiently complete to permit substantive review. It does not mean it will be approved.

Industry response

As reported by Stat: “Overall, there’s some improvement,” said Robert Pollock, a former acting deputy director of the FDA Office of Generic Drugs, who now works at Lachman Consultants and advises drug makers on regulatory matters. “But the question is can it be sustained, and will there be progress beyond what we’ve seen.”

Stat explains that generic drug approval is getting more attention due to the national debate over drug costs. Generics now account for 88 percent of all prescriptions written in the United States, according to IMS health. As a result, FDA’s leadership has stressed its work on accelerating generic approvals. And as Stat notes, Adam Fein of Pembroke Consulting, who tracks pharmaceutical distribution, contends the increasing number of approvals is starting to temper the price hikes for generic drugs. But historically, the FDA has been unable to keep up with the pace of marketing applications filed by generic drug makers.

Next GDUFA

Regulatory Focus notes that the median time to market has fallen considerably as GDUFA has progressed. For the fastest 5% of ANDAs approved under GDUFA, the median approval time has gone from about 24 months in FY 2013 to less than 15 months in FY 2015. However, under the next iteration of GDUFA, which will take effect in FY2018, ANDA standard review time will likely be 10 months from submission and priority review would be eight months from submission.

This is compared to the 42- to 44-month average approval time before GDUFA was in place. However, ANDA submissions do continue to outpace approvals and criticism of the median approval times does seem warranted according to Regulatory Focus, when considering that it takes FDA only 10 months to review and approve much more complex new drug submissions.

April 17, 2017

Maryland Sends Bill to Governor on Drug Prices

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The Maryland House recently passed a bill – House Bill 631 – with the goal of “prohibiting a manufacturer or wholesale distributor from engaging in price gouging in the sale of an essential off-patent or generic drug.”

Under the legislation, the Maryland Medical Assistance Program is instructed to notify Maryland Attorney General if a generic drug’s price spikes by 50% or more in one year, or if its price increases while there are three (or less) companies making the prescription. Once the Attorney General Receives that notice, he or she is able to request a report from manufacturers, detailing production costs, rationale for the price hike, and efforts made to expand access.

If the Attorney General determines that the company violated the pricing law, he or she can request that a local circuit court force it to roll back the price and return money to consumers. That court can also impose a fine of up to $10,000.00 for each violation under the law.

Chester Davis, Jr., President and CEO of the Association for Affordable Medicines, has issued a statement asking for a veto of the bill, stating, “it is threatening the savings patients and taxpayers receive from affordable generic drugs.” He further notes, “in 2015 generic drugs delivered $227 billion in savings to the U.S. healthcare system, and $1.6 trillion in savings over the last decade. For that same calendar year, generic drugs comprised 89% of all prescriptions written in the United States, but accounted for only 27% of total prescription drug costs.”

Davis expresses concern about unintended consequences, “While the desire to take action against bad actors in the industry is understandable, what has been utterly lost in the debate over prescription drug costs in Maryland this session is the law of unintended consequences; namely, that by giving the Attorney General this unbounded and unprecedented level of authority to control pricing in a competitive free market, generic companies will be exposed to a level of risk in Maryland that will require them to evaluate whether they want to continue to market affordable medicines within the state.”

The current Maryland Attorney General, Brian Frosh, applauded the legislation. In a statement released by his office, he stated that the legislation gives Maryland a “necessary tool to combat unjustified and extreme price increases for medicines that have long been on the market and that are essential to our health and well-being.”

Maryland Governor Larry Hogan has not yet signed the bill.

Other State Actions

In New York, Governor Andrew Cuomo has proposed the idea of creating a board to control the costs of drug by allowing that board to determine a “fair price.” This idea has been introduced several times before the Legislature, each time soundly defeated.

Last year, California voters turned down a ballot initiative that would have limited industry’s power to create their own pricing. Now, industry is preparing for a fight in Nevada. A state senator recently introduced a measure to control prices on certain drugs, and the industry is enlisting lobbyists for the fight, according to the publication.

At the national level, President Donald Trump has repeatedly pledged to lower costs through increasing “competition,” while Congress considers proposals for drug importation and Medicare price negotiations. Rep. Elijah Cummings, an influential congressman from Maryland, has been involved in those talks and met with Trump to share his importation proposal earlier this year.

April 06, 2017

Senators Ask GAO to Investigate Potential Orphan Drug Act Abuse

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In a March 3, 2017, letter to the United States Government Accountability Office, Senators Orrin Hatch, Chuck Grassley, and Tom Cotton raised the idea that regulatory or legislative changes might be needed to “preserve the intent of this vital law” that gives drug makers lucrative incentives to develop drugs for rare diseases.

The letter notes that, “[w]hile few will argue against the importance of the development of these drugs, several recent press reports suggest that some pharmaceutical manufacturers might be taking advantage of the multiple designation allowance in the orphan drug approval process.”

The senators ask for a list of drugs that have been approved or denied orphan status by the Food and Drug Administration (FDA), also asking whether resources at the FDA have been able to keep up with the “number of requests” from drug makers and whether there is consistency in the department’s reviews.

The senators also expressed concern about patients, saying in their letter that “we feel it is important to include the patient voice in your review.”

Few senators are in a position to alter the law. However, the three authors of this letter are in such a position. Hatch, a longtime advocate of the rare disease community, said late Monday in a statement that there was little evidence to suggest the Orphan Drug Act needs to change.

Hatch is chairman of the Senate Finance Committee, which oversees 50 percent of the federal budget, including Medicaid and Medicare spending. He said the letter is requesting “the first GAO study exclusively reviewing the Orphan Drug Act, and such oversight will ensure those critical innovations are continued into the future.”

Grassley, the senior senator from Iowa, chairs the Judiciary Committee and has jurisdiction over anti-competitive and patent-related issues. Grassley last month announced an inquiry into the Orphan Drug Act in response to KHN’s investigation.

Cotton, a strong conservative voice, chairs the subcommittee on economic policy under the committee on banking, housing and urban affairs. In a floor speech last month, he announced that he would find a legislative solution to price hikes associated with the orphan drug program.

Kaiser Health News Investigation

This letter comes on the heels of a January investigation published by Kaiser Health News (KHN) that found the orphan drug program is being manipulated by drug makers to maximize their profits and protect niche markets for particular medicines.

Recently, orphan drugs have come under fire (along with the rest of the industry) for high prices. The investigation by KHN found that many drugs that now have orphan status are not entirely new – more than seventy were drugs that were first approved by the FDA for mass-market use. Others (roughly numbering eighty) are drugs that have received multiple exclusivity periods for two or more rare conditions.

Marathon Pharma Hikes Emflaza Price

Senators have been incensed by actions taken by Marathon Pharmaceuticals, manufacturer of Emflaza, a corticosteroid approved to treat Duchenne muscular dystrophy. Marathon recently announced an $89,000 annual list price for the drug, which many U.S. patients have purchased overseas for $1,000 to $1,600 a year.

Marathon responded in February by delaying the rollout of the drug, saying it will talk with stakeholders, including patients, about the price.

Eight senators sent a letter to Marathon CEO Jeff Aronin demanding information on the private drug maker’s pricing strategy. Marathon spokeswoman Wanda Moebius released a statement saying the company is committed to ensuring that all patients who need this drug have access to it and will continue to work with the Duchenne community.

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