The Thriving Compounding Pharmacy Industry In Tampa Bay

The Thriving Compounding Pharmacy Industry In Tampa Bay

DRUG COMPOUNDING: Clear Authority and More Reliable Data Needed to Strengthen FDA Oversight GAO-13-702, Jul 31, 2013

50 page report is available http://www.gao.gov/products/GAO-13-702?source=rahere

What GAO Found

The authority of the Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), to oversee drug compounding is unclear. Two federal circuit court decisions have resulted in differing FDA authority in different parts of the country. According to FDA officials, these inconsistent decisions and the agency's limited inspection authority over pharmacies have created challenges in FDA's ability to inspect and take enforcement action against entities engaging in drug compounding. For example, from 2002 through 2012, in order to inspect some facilities engaged in drug compounding, FDA officials said they had to obtain 11 warrants to gain access to drug compounders' facilities that had challenged FDA's inspection authority. GAO also found that while FDA and national pharmacy organization officials generally agreed that states regulate the practice of pharmacy and FDA regulates drug manufacturing, there was no consensus on whether compounding drugs in large quantities--in anticipation of individual prescriptions or without prescriptions--and selling those drugs across state lines falls within the practice of pharmacy or is a type of drug manufacturing that should be overseen by FDA. This lack of consensus and differing FDA authority to oversee compounded drugs across the country has resulted in gaps in oversight of drug compounding.

FDA lacks timely and reliable information to oversee the entities that compound drugs, but has found problems through its limited oversight. Specifically, FDA's inspection database cannot identify all of the agency's inspections of compounding pharmacies, or the final classification of inspection results, for all of the inspections. Until 2013, FDA limited its inspections of compounding pharmacies to those conducted in response to complaints or adverse events. However, the agency recently inspected compounding pharmacies that it identified as posing a significant threat to public health from poor sterile drug production practices in the past and found problems, such as concerns about a lack of sterility, which resulted in recalls of compounded drugs. In addition, drug manufacturers are required to register with FDA and are subject to FDA's inspection and drug approval processes; pharmacies meeting certain requirements are generally exempt from registration. However, some compounding pharmacies may have registered with FDA to market themselves as "FDA-registered" which may lead some purchasers to assume that FDA has inspected or approved their compounded drugs; whereas, according to FDA officials, this is generally not the case.

The states GAO reviewed--California, Connecticut, Florida, and Iowa--have each taken actions to enhance their oversight of drug compounding. For example, Florida required all pharmacies--both those located in the state and out-of-state that sell drugs in Florida--to notify the board of their compounding activities. In addition, national pharmacy organizations have undertaken efforts to help states oversee drug compounding. For example, a national pharmacy organization is working with Iowa to inspect out-of-state pharmacies that ship drugs into the state. However, according to national pharmacy organizations and officials from state boards of pharmacy, some states do not have the resources to inspect pharmacies on a regular basis. Instead, these states inspect pharmacies only in response to a complaint or a reported adverse drug event.

Why GAO Did This Study

Drug compounding is the process by which a pharmacist combines, mixes, or alters ingredients to create a drug tailored to the medical needs of an individual. An outbreak of fungal meningitis in 2012 linked to contaminated compounded drugs has raised concerns about state and federal oversight of drug compounding. GAO was asked to update its 2003 testimony on drug compounding. Specifically, this report addresses (1) the status of FDA's authority to oversee drug compounding, and the gaps, if any, between state and federal authority; (2) how FDA has used its data and authority to oversee drug compounding; and (3) the actions taken or planned by states or national pharmacy organizations to improve oversight of drug compounding. GAO reviewed relevant statutes and guidance; reviewed FDA data; and interviewed officials from FDA, national pharmacy organizations, and four states with varied geography, population, and pharmacy regulations.

What GAO Recommends

To help ensure that the entities that compound drugs have appropriate oversight, Congress should consider clarifying FDA’s authority to oversee drug compounding. In addition, FDA should ensure its databases collect reliable and timely data on inspections associated with compounded drugs, and differentiate drug compounders from manufacturers. HHS's comments support the need to clarify FDA's authority, and stated that the information in its inspection database could be improved and that it would consider whether it can differentiate compounding pharmacies from manufacturers.

APIC | APIC endorses compounding oversight legislation

APIC | APIC endorses compounding oversight legislation

'Sunshine-ing' on Docs Signals End to Pharma Largesse

WASHINGTON -- There aren't many gifts physicians can take from drug companies after this week without it becoming publicly reported.

Maybe a low-cost breakfast or midday snack and coffee. The little knick-knacks given out at exhibit booths. (Drug companies don't give office supplies like pens and note pads any more.)

Starting Thursday, drug and device manufacturers and group purchasing organizations must report payments or gifts in excess of $10 made to physicians in a yearly basis under the Physician Payments Sunshine Act. Those payments will be displayed on a public website starting next fall.

"A lot of items are going to be reported," Tom Sullivan, president of the medical consulting group Rockpointe Corporation in Columbia, Md., told MedPage Today in a phone interview.

There are a few exceptions, according to the American Academy of Family Physicians:

• Gifts or payments valued at less than $10 -- unless the aggregate amount paid to the physician exceeds $100 annually
• General food and drinks offered to all participants at conferences or large-scale events
• Educational materials and items intended for use by or with patients
• Samples intended for patient use, including coupons and vouchers for obtaining samples
• Payments or other transfers of value to residents

Medical groups also pushed hard for CMS to exempt speaker fees for accredited continuing medical education programs, which CMS granted. Publicly reporting such information would have a "chilling effect on doctors if they want to go to an accredited event that they'll show up on this public Open Payments database," Andy Rosenberg, JD, senior adviser at theCME Coalition, a group of CME sponsors and providers, told MedPage Today.

Pharmaceutical companies underwrite about a third of today's accredited CME programs, he said.

Programs approved by the Accreditation Council for Continuing Medical Education, the American Dental Association's Continuing Education Recognition Program, the American Academy of Family Physicians, the American Medical Association, and the American Osteopathic Association are exempt from public reporting.

Although data collection starts Thursday, CMS won't release the data on the public website till Sept. 20, 2014. Manufacturers must report the data to CMS by March 31, 2014. CMS will post the information on its website on June 30 in subsequest years.

But CMS will allow physicians 45 days to dispute the data before they are public, and doctors can seek corrections within a 2-year period. The agency and medical groups like theAmerican Medical Association are encouraging providers to take those steps and open a dialogue with patients about transparency.

Physicians can register with CMS starting Jan. 1 to receive a report on their activities each June before the public report is released. CMS also is pushing the smartphone application called "Open Payments Mobile for Physicians" which tracks payments and other value transfers manufacturers will report.

"Physicians can certainly access the website on which manufacturers report the information and see whether the information the manufacturers report matches the doctors' own understanding and then request revisions if they believe those are required," Alan Sager, professor of health policy and management at Boston University, told MedPage Today in a video interview.

Sullivan said he doesn't expect much to change in the doctor-drug company relationship, just more tracking and reporting on interactions between the two sides.

"I don't see pharma changing a whole lot of how they do business other than writing down who they do business with," Sullivan said.

 

 

Quesion of the Day July 31, 2013 Do organizations such as IACP which advocated in the past for its members to resist FDA inspections or PCAB which granted accrediation to compounding pharmacies have any civil or criminal liability in the deaths and illness from compounding medications?